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T-SLING
HERNIAMESH SRL · Model 5194001400 · UDI-DI 28032919892120
PAH
Prescription
10
510(k) clearances
5,985
Adverse events (100 deaths)
1
Recalls
15
Facilities
Description
The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for the treatment of stress urinary incontinence (SUI).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-10-26 | Astora | The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box 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.