MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for MEPILEX / BORDER POST-OP AG SILICONE DRESSING 498600 manufactured by Molnlycke Healthcare Us Llc.
[180768289]
Mepilex border post-op ag, 4" x 12" dressing was noted to have a tannish / brown coloration when it was opened at the end of the case. This dressing was not used and replaced with another dressing that had the normal grayish color. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093164 |
| MDR Report Key | 9739430 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-11 |
| Date Added to Maude | 2020-02-21 |
| 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 / BORDER POST-OP AG SILICONE DRESSING |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-02-20 |
| 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 HEALTHCARE US LLC |
| Manufacturer Address | NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |