MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for SERI SURGICAL SCAFFOLDING manufactured by Allergan.
[50822186]
Had diep flap surgery with my mastectomy. They used seri surgical scaffolding. I had severe pain, infections and it became encapsulated. It had to be removed in (b)(6) 2016. I am still in quite a bit of pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063711 |
| MDR Report Key | 5832722 |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-26 |
| Date of Event | 2015-03-03 |
| Date Added to Maude | 2016-07-29 |
| 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 | PATIENT |
| 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 | SERI SURGICAL SCAFFOLDING |
| Generic Name | SERI SURGICAL SCAFFOLDING |
| Product Code | OXF |
| Date Received | 2016-07-26 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-07-26 |