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MPM Cool Magic
Mpm Medical, LLC · Model 6 · UDI-DI 00366977208680
10
510(k) clearances
97
Adverse events (20 deaths)
14
Recalls
50
Facilities
Description
MPM CoolMagic Clear Hydrogel Sheet Wound Drsg. strl 6X8. Packaged as follows: 10 Dressings Per sbs; 3 sbs per case
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2015-03-26 | PhotoMedex, Inc. | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearan |
| 2015-02-25 | Amerx Health Care Corp. | Nonapproved labeling claims (Sterile) |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
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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.