MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3) CON3006 manufactured by Lifecell.
[188139187]
The strattice will not be returned as it was discarded. Qa investigation into lot sp200083 resulted in no remarkable findings including 414 devices distributed with no similar complaints against the lot and no processing deviations or nonconformances related to the nature of this complaint. Lot sp200083 was terminally sterilized and met all qc release criteria.
Patient Sequence No: 1, Text Type: N, H10
[188139188]
It was reported that the patient experienced a recurrence of capsular contracture with baker grade iii. The strattice was placed on (b)(6) 2020 and removed on (b)(6) 2020. Lot sp200083 was affected and discarded after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306051-2020-00011 |
| MDR Report Key | 9781396 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-02-22 |
| Date Added to Maude | 2020-03-03 |
| 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 | MR. CHRISTOPHER BELLE |
| Manufacturer Street | 1 MILLENNIUM WAY |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9089471470 |
| Manufacturer G1 | LIFECELL |
| Manufacturer Street | 1 MILLENNIUM WAY |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3) |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-03 |
| Catalog Number | CON3006 |
| Lot Number | SP200083 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFECELL |
| Manufacturer Address | 1 MILLENNIUM WAY BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |