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H&H
TRONJEN MEDICAL TECHNOLOGY INC. · Model SH0505 · UDI-DI 04719859642045
10
510(k) clearances
18,954
Adverse events (8 deaths)
19
Recalls
514
Facilities
Description
Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-29 | ConvaTec, Inc | Wound dressing may have foreign matter on the product. |
| 2025-02-19 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for the sterility of the device to be compromised. |
| 2022-01-28 | Sam Medical Products | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov |
| 2021-08-20 | ConvaTec, Inc | Primary packaging labeling may be incorrect. |
| 2021-08-09 | ConvaTec, Inc | There is a potential for open seals which can compromise sterility. |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
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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.