MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-08 for REGARD LAP SPONGE manufactured by Unk.
[85639626]
Lap sponge falling apart. Small threads from lap sponge were being pulled out from pt at implant site. Diagnosis or reason for use: used during surgery; breast enlargement. Therapy date: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072063 |
| MDR Report Key | 6851707 |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-09-06 |
| Date Added to Maude | 2017-09-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | REGARD LAP SPONGE |
| Generic Name | REGARD LAP SPONGE |
| Product Code | EFQ |
| Date Received | 2017-09-08 |
| Lot Number | 046301P |
| Device Expiration Date | 2019-01-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-08 |