MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-03-27 for PCO VENTRAL PATCH 4C PCO4VP manufactured by Sofradim Production.
[5753196]
Procedure: hernia repair. According to the reporter, the mesh would not deploy. It would fold onto itself. The surgeon tried three times to place and was unable to fixate it. The surgical time was extended by 15 min. Sample will not be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[13060350]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[13360263]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615742-2015-00018 |
| MDR Report Key | 4637653 |
| Report Source | 01,06 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-04-29 |
| 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 | 2034925267 |
| Manufacturer G1 | SOFRADIM PRODUCTION |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCO VENTRAL PATCH 4C |
| Generic Name | MESH |
| Product Code | OXJ |
| Date Received | 2015-03-27 |
| Returned To Mfg | 2015-04-27 |
| Model Number | PCO4VP |
| Catalog Number | PCO4VP |
| Lot Number | PNL0168 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-27 |