MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-19 for PACO VENTRAL PATCH 4 C PCO4VP manufactured by Sofradim Production.
[4749364]
Umbilical hernia. Mesh ripped. Expander ring broke during implantation. No injury to the pt. Did not add excessive time to the procedure. The issue was resolved by opening a fresh unit. There was no unanticipated tissue loss. There was no tissue damage. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 mins.
Patient Sequence No: 1, Text Type: D, B5
[12217187]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615742-2014-00171 |
| MDR Report Key | 3987856 |
| Report Source | 05 |
| Date Received | 2014-05-19 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2014-08-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925670 |
| Manufacturer G1 | SOFRADIM PRODUCTION |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX F01600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F01600 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACO VENTRAL PATCH 4 C |
| Generic Name | PCO VENTRAL PATCH |
| Product Code | OXJ |
| Date Received | 2014-05-19 |
| Catalog Number | PCO4VP |
| Lot Number | PNI0214 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX F-01600 FR F-01600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-19 |