MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for PARIETEX COMPOSITE PCO2015 manufactured by Tyco Healthcare/covidien.
[72806478]
Had to have a penniculectomy because fat necrosis had grown onto mesh and was hurting. I've been hospitalized and had two hernia repairs since then, both times i had additional mesh installed, on (b)(6) 2014 and (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069071 |
| MDR Report Key | 6489443 |
| Date Received | 2017-04-11 |
| Date Added to Maude | 2017-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARIETEX COMPOSITE |
| Generic Name | PARIETEX COMPOSITE |
| Product Code | FTL |
| Date Received | 2017-04-11 |
| Model Number | PCO2015 |
| Lot Number | PKJ00661 |
| Device Expiration Date | 2015-11-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE/COVIDIEN |
| Brand Name | PARIETEX COMPOSITE |
| Generic Name | PARIETEX COMPOSITE |
| Product Code | FRL |
| Date Received | 2017-04-11 |
| Model Number | PCO2015 |
| Lot Number | PKJ00661 |
| Device Expiration Date | 2015-11-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE/ COVIDIEN |
| Brand Name | PARIETEX COMPOSITE |
| Generic Name | PARIETEX COMPOSITE |
| Product Code | FTL |
| Date Received | 2017-04-11 |
| Model Number | PCO2015 |
| Lot Number | PKJ00661 |
| Device Expiration Date | 2015-11-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE/ COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-04-11 |