MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for MESH SOFRADIM - PARIETEX? COMPOSITE MESH PCO3728 manufactured by Sofradim Production Sas.
[188065280]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188065281]
The patient? S attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of multiple incisional hernias. It was reported that after the implant, the patient experienced recurrence, pain, adhesions, abdominal pain, infection, mesh had areas of laxity and hardness, necrosis, and mesh indurated. Post-operative patient treatment included revision surgery, debridement of wound, excised mesh, lysis of adhesions, small bowel resection with anastomosis, removal of some of the infected area of synthetic mesh in lower abdominal area, removal of excess skin and subcutaneous tissue off the abdominal wall, repair a dome of the bladder cystotomy, wound vac, wound dressings, debridement of necrotic abdominal wall skin, subcutaneous tissue and fascia with reclosure of the complicated abdominal wall wound defect, prolene sutures removed, and recurrent incisional hernia repaired with new bard mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2020-00754 |
| MDR Report Key | 9900713 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| 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 | SOFRADIM PRODUCTION SAS |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX 01600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 01600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESH SOFRADIM - PARIETEX? COMPOSITE MESH |
| Generic Name | MESH, SURGICAL, POLYMERIC |
| Product Code | FTL |
| Date Received | 2020-03-30 |
| Model Number | PCO3728 |
| Catalog Number | PCO3728 |
| Lot Number | PIF00397 |
| Device Expiration Date | 2013-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION SAS |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX 01600 FR 01600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |