MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for PERMACOL P101015 manufactured by Tissue Science Laboratories.
[186609219]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186609220]
The patient? S attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after the implant, the patient experienced infection, fistula, inflammation, failure of mesh, and exposed mesh. Post-operative patient treatment included revision surgery, would exploration and debridement, mesh removal, and wound vac placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617613-2020-00044 |
| MDR Report Key | 9888894 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | TISSUE SCIENCE LABORATORIES |
| Manufacturer Street | VICTORIA HOUSE, VICTORIA ROAD |
| Manufacturer City | ALDERSHOT, HAMPSHIRE GU111EJ |
| Manufacturer Country | GB |
| Manufacturer Postal Code | GU11 1EJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMACOL |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-27 |
| Model Number | P101015 |
| Catalog Number | P101015 |
| Lot Number | 07B07-4 |
| Device Expiration Date | 2011-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TISSUE SCIENCE LABORATORIES |
| Manufacturer Address | VICTORIA HOUSE, VICTORIA ROAD ALDERSHOT, HAMPSHIRE GU111EJ GB GU11 1EJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |