MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-02 for PCO VENTRAL PATCH 4C PCO4VP manufactured by Sofradim Production.
[12482781]
(b)(4). According to the reporter, the original procedure was a hernia repair. The "recurrence" described in the initial report was a recurrence of hernia.
Patient Sequence No: 1, Text Type: N, H10
[16175099]
According to the reporter:patient came to hospital on (b)(6), because if suigns of recurrance. Recurrence dianosed by physical examination and ultrasound. For the moment conservative treatment. No operation medical history: copd, hyperthyroid, psoriasis, heartburn.
Patient Sequence No: 1, Text Type: D, B5
[16439744]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615742-2014-00313 |
| MDR Report Key | 4134484 |
| Report Source | 06 |
| Date Received | 2014-10-02 |
| Date of Report | 2014-09-09 |
| Date of Event | 2013-10-03 |
| Date Mfgr Received | 2014-09-09 |
| Date Added to Maude | 2014-10-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06743 |
| Manufacturer Country | US |
| Manufacturer Postal | 06743 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | SOFRADIM PRODUCTION |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX |
| Manufacturer Country | FR |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCO VENTRAL PATCH 4C |
| Generic Name | PCO VENTRAL PATCH |
| Product Code | OXJ |
| Date Received | 2014-10-02 |
| Model Number | PCO4VP |
| Catalog Number | PCO4VP |
| Lot Number | PND0716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2014-10-02 |