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HidraWear
HIDRAMED SOLUTIONS LIMITED · Model GBB002-02 · UDI-DI 05391535510399
MDR
Prescription
0
510(k) clearances
2
Adverse events (1 deaths)
19
Recalls
69
Facilities
Description
The HidraWear BB Men’s Boxer Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Men’s Boxer Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular briefs and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
| 2010-04-20 | Circaid Medical Products Inc | Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension a |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.