MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-24 for MESH TSL - PERMACOL? UNKNOWN-PERMACOL manufactured by Sofradim Production Sas.
[187613162]
(b)(4). Title perioperative complications of complex abdominal wall reconstruction with biologic mesh: a pooled retrospective cohort analysis of 220 patients from two academic centers source international journal of surgery, volume 74, 2020 (94? 99) date of publication: 28 december 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187613203]
According to the literature source of study performed aimed to identify perioperative predictors of outcomes after complex abdominal wall reconstruction (cawr) with biologic mesh (bm). In this retrospective study, perioperative complications were analyzed in all patients who underwent open cawr with bm over six years in two academic centers. There were 220 patients included in the study and 8 were implanted with the company's complication. Post-operatively wound infections were reported in 28 patients and 26 of them required a wound vacuum-assisted closure. 13 patient require mechanical ventilation and 47 of the patient require reoperation. The reasons for patient reoperation were not reported. Which mesh was used in the reported adverse events was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2020-00624 |
| MDR Report Key | 9872351 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-24 |
| 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 TSL - PERMACOL? |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-24 |
| Model Number | UNKNOWN-PERMACOL |
| Catalog Number | UNKNOWN-PERMACOL |
| 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. Other | 2020-03-24 |