MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-04 for MEPITEL UNK 290790 manufactured by Molnlycke Health Care.
[3912856]
According to the doctor, his pt had a reaction to mepitel when it was placed over an apligraft. The reaction to the mepitel caused demarcation of the skin graft. The nurse shared that as far as she knew the pt did not have to have surgery and is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[11155876]
No review of the device history record could be conducted as no lot number or sample was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004763499-2013-00009 |
| MDR Report Key | 3410154 |
| Report Source | 00 |
| Date Received | 2013-10-04 |
| Date of Report | 2013-10-04 |
| Date of Event | 2013-08-09 |
| Date Mfgr Received | 2013-08-14 |
| Date Added to Maude | 2013-10-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRACEY MURRAY |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 6782507912 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEPITEL |
| Generic Name | MEPITEL |
| Product Code | MGP |
| Date Received | 2013-10-04 |
| Model Number | UNK |
| Catalog Number | 290790 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTH CARE |
| Manufacturer Address | NORCROSS GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-04 |