MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-05 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[3035232]
Multisystem organ failure [multi-organ failure]. Case description: spontaneous report was rec'd on (b)(4) 2012 from a physician assistant 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 was grafted with 96 grafts of epicel (lot # ee01633). On (b)(6) 2012, the pt was grafted with 96 grafts of epicel (lot # ee01633a). On (b)(6) 2012, the pt was grafted with 96 grafts of epicel (lot # ee01641). On an unspecified date, the pt experienced multisystem organ failure (start date unspecified) and died on (b)(6) 2012. Concomitant medications were not provided. The intensity for the event of multisystem organ failure was not provided. The relationship between epicel and the event of multisystem organ failure was not provided by the rptr. The sterility and environmental monitoring results were rec'd on (b)(4) 2012. All sterility results for the production of epicel lot ee01633 were negative for contamination. On (b)(4) 2012, add'l info was rec'd in the form of the biopsy transmittal form. Pt initials were updated to (b)(6). The pt's height and weight were reported as (b)(6), respectively. On (b)(6) 2012, the pt sustained 70% total body surface area burns, with 40% second degree burns and 30% third degree burns and was admitted to the hospital. The pt's biopsy were taken on (b)(6) 2012 from the right and left groin.
Patient Sequence No: 1, Text Type: D, B5
[10215009]
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 | 1226230-2012-00005 |
| MDR Report Key | 2780199 |
| Report Source | 05,07 |
| Date Received | 2012-10-05 |
| Date of Report | 2012-09-25 |
| Date Mfgr Received | 2012-09-25 |
| Date Added to Maude | 2012-10-11 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Street | 64 SIDNEY STREET |
| 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 | 2012-10-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01633A |
| ID Number | UNK |
| 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 | 2012-10-05 |