MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-30 for MEPITEL ONE 289670-00 manufactured by Molnlycke Health Care.
[3783083]
(b)(6) boy had friction burn on the back of his hand that had been grafted during surgery, mepitel one was applied to the graft and then a secondary dressing on top. The boy was brought back to theatre 48 hours later, saline was poured over the dressing, which made the safetac tacky, the dressing was then removed, which also removed the skin graft.
Patient Sequence No: 1, Text Type: D, B5
[11375877]
Based on the available information, this event is deemed a serious injury. The use of mepitel one for fixating grafts is within the intended use. There is a causal link to the product, although removal of the dressing already after 48 hours is deemed far too early. This is supported by the precautions located in the product instructions for use. "when mepitel one is used for fixation of skin grafts, the dressing should not be changed before the fifth day post application. " no additional patient/ event information has been provided to date. A return sample for evaluation is not expected. Should additional information become available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004763499-2013-00018 |
| MDR Report Key | 3452561 |
| Report Source | 00 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2013-10-22 |
| Date Added to Maude | 2013-11-07 |
| 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 | ANGELA BUNN, DIRECTOR |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 6782507930 |
| Manufacturer G1 | MOLNLYCKE HEALTHCARE OY |
| Manufacturer Street | SAIMAANUKATU 6 FI-50101 |
| Manufacturer City | MIKKELI 10 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 10 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEPITEL ONE |
| Generic Name | MEPITEL ONE |
| Product Code | MGP |
| Date Received | 2013-10-30 |
| Model Number | NA |
| Catalog Number | 289670-00 |
| Lot Number | 13288780 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-10-30 |