MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-25 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[15111869]
This unsolicited device case from united states received on (b)(4) 2014 from a non-healthcare professional. This case concerns a pt (unspecified demographics) who expired due to unreported cause after grafting with epicel cultured epidermal autografts (epicel). No past medications, medical history, or concurrent conditions and concomitant conditions were reported. An unk date in 2012, the pt was grafted with epicel cultured epidermal autografts (batch/lot number: ee101624 and expiration date: unk) on an unspecified location for thermal burns. On (b)(6) 2013, (51 days following grafting with epicel cultured epidermal autografts), the pt expired due to an unreported cause. Corrective treatment: not reported. A pharmaceutical technical complaint (ptc) was initiated and conclusion was pending for the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2014-20952 |
| MDR Report Key | 3677061 |
| Report Source | 04 |
| Date Received | 2014-02-25 |
| Date of Report | 2014-02-14 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2014-02-14 |
| Date Added to Maude | 2014-03-14 |
| 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 Street | 55 CORP DR MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089816698 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2014-02-25 |
| Lot Number | EE101624 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Address | CAMBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-02-25 |