MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for SERI MESH SCAFFOLD 94675/ SCF10X25AGEN manufactured by Sofregen (prev Allergan).
[78472069]
Surgery to include seri mesh scaffold (allergan manufactured) since now they have sold to sofregen medical, since initial install on (b)(6) 2015 - leading to infection which has resulted in multiple surgeries to remove, efforts to correct damaging effects from the medical device and long term antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070605 |
| MDR Report Key | 6666616 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2015-06-23 |
| Date Added to Maude | 2017-06-26 |
| 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 CAREGIVERS |
| 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 MESH SCAFFOLD |
| Generic Name | SERI MESH |
| Product Code | OXF |
| Date Received | 2017-06-22 |
| Catalog Number | 94675/ SCF10X25AGEN |
| Lot Number | P14091501A |
| Device Expiration Date | 2017-10-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFREGEN (PREV ALLERGAN) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-06-22 |