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 SYMBOTEX SYM1510 manufactured by Sofradim Production Sas.
[186527646]
Concomitant medical products: pco2h3 parietex comp hiatal 3d py 9x8cm (lot# pnk0644x). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186527647]
The patient? S attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of a hiatal hernia and a ventral hernia. It was reported that after implant, the patient experienced adhesions, scar tissue, and mesh erosion. Post-operative patient treatment included revision surgery, lysis of adhesions, and removal of hiatal hernia mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2020-00741 |
| MDR Report Key | 9891571 |
| 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 | SYMBOTEX |
| Generic Name | MESH, SURGICAL, POLYMERIC |
| Product Code | FTL |
| Date Received | 2020-03-27 |
| Model Number | SYM1510 |
| Catalog Number | SYM1510 |
| Lot Number | PN30237X |
| Device Expiration Date | 2016-09-30 |
| 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 | 2020-03-27 |