MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for MEPILEX DRESSING BORDER POST-OP AG 498600 manufactured by Molnlycke Health Care Us Llc.
[176043771]
Mepilex border post-op ag dressing was discolored, a brownish color, when the sterile packaging was opened x 2 dressings with the same lot number. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092365 |
| MDR Report Key | 9610858 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-01-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEPILEX DRESSING BORDER POST-OP AG |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-01-17 |
| Model Number | 498600 |
| Catalog Number | 498600 |
| Lot Number | 19319608 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTH CARE US LLC |
| Manufacturer Address | NORCROSS GA 30092 US 30092 |
| Brand Name | MEPILEX DRESSING BORDER POST-OP AG |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-01-17 |
| Model Number | 498600 |
| Catalog Number | 498600 |
| Lot Number | 19319608 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTH CARE US LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |