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 PARIETEX PCO20X manufactured by Sofradim Production Sas.
[186346415]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186346416]
The patient? S attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced recurrence, adhesions, abdominal pain, chronically low platelet count, ischemic bowel, blood loss, and left side of mesh was completely detached from abdominal wall. Post-operative patient treatment included revision surgery, antibiotics/fluids, removal of mesh, hernia repair with new mesh, administration of crystalloid, albumin, 1 unit of platelets and 1 unit of ffp, and admission to hospital/icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2020-00745 |
| MDR Report Key | 9891703 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-04 |
| 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 | 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 | PARIETEX |
| Generic Name | MESH, SURGICAL, POLYMERIC |
| Product Code | FTL |
| Date Received | 2020-03-27 |
| Model Number | PCO20X |
| Catalog Number | PCO20X |
| Lot Number | PMC00643 |
| Device Expiration Date | 2014-03-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |