MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-30 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[3059391]
Expired [death]. Case description: spontaneous report was received on (b)(6) 2012 (additional info was received on (b)(6) 2012) from a nurse via a company rep regarding a (b)(6) male pt, initials (b)(6) with thermal burn. The pt's medical history was not provided. On (b)(6) 2012, the pt sustained 35 percent tbsa (total body surface area) burns. The pt was diagnosed with wound infection (acinetobacter) and systemic infection (pseudomonas, candida). On (b)(6) 2012, left and right groin biopsies were performed. On (b)(6) 2012, the pt was grafted with epicel (lot # ee01619). All sterility results and environmental monitoring results for the production of epicel were negative for contamination. On (b)(6) 2012, the pt expired due to an unk cause. It was reported that the pt expired after receiving skin grafts which were not related to the grafts themselves. Relevant concomitant medications reported include cipro (ciprofloxacin), meronem (meropenem), mycamine (micafungin sodium), silvadene (sulfadiazine silver) and acticoat. The intensity for the event was severe. The reporter did not provide relationship between epicel and the event.
Patient Sequence No: 1, Text Type: D, B5
[10465172]
Mfr's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00009 |
| MDR Report Key | 2887538 |
| Report Source | 05,07 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-20 |
| Date Mfgr Received | 2012-11-20 |
| Date Added to Maude | 2012-12-28 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Street | 64 SIDNEY ST. |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2012-11-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01619 |
| ID Number | UNK |
| Device Expiration Date | 2012-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-11-30 |