MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-06 for PERMACOL P101010 manufactured by Tissue Science Laboratories.
[187252896]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187252897]
The patient? S attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hiatal hernia. It was reported that after implant, the patient experienced mesh "folded over the anterior esophagus," mesh migration and scarring. Post-operative patient treatment included two removal surgeries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617613-2020-00038 |
| MDR Report Key | 9800102 |
| Report Source | CONSUMER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Model Number | P101010 |
| Catalog Number | P101010 |
| Lot Number | 09B0808 |
| Device Expiration Date | 2012-07-31 |
| 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 | 2020-03-06 |