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 6 X 10 FIRM STRATTICE FOR CA DISTRIBUTION 0610008CA manufactured by Lifecell.
| Report Number | 1000306051-2020-00009 |
| MDR Report Key | 9780851 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2018-04-03 |
| 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 | 6 X 10 FIRM STRATTICE FOR CA DISTRIBUTION |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-03 |
| Catalog Number | 0610008CA |
| Lot Number | SP100616 |
| Device Expiration Date | 2020-02-29 |
| 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 |