MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for ACELL MESH manufactured by Acell, Inc..
[182922850]
A-cell biological mesh was implanted during an abdominal hernia repair at (b)(6) hosp. I immediately experienced adverse rejection effects, including fever and pulmonary embolisms. I developed sepsis, new hernias, seromas and abscesses. The mesh formed a ball, my body formed a thick capsule around it. This "mesh ball" was removed at (b)(6) hospital in (b)(6) 2019 and i was on a wound vac until (b)(6) 2019. The remaining mesh continued to cause problems with abscesses and fevers. I had another removal surgery (b)(6) 2019. Despite mesh removal, i developed an abscess in (b)(6) 2020. I believe this mesh is faulty and should be removed from the market. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093617 |
| MDR Report Key | 9805319 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-01-09 |
| Date Added to Maude | 2020-03-09 |
| 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 | 3 |
| Brand Name | ACELL MESH |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-06 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-03-06 |