MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-21 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[3049033]
Embolism [embolism]. Case description: spontaneous report was received on (b)(6) 2012 from a nurse via sales representative regarding a female patient (initials and age not provided) with thermal burn. The patient's medical history was not provided. On (b)(6) 2012, the patient was grafted with 144 grafts of epicel (#(b)(4)) at hospital. It was reported that initially the patient's graft uptake was 80%, which developed and held well one month post-grafting. The patient was eating normal food and was in good spirits. It was reported that, as the nursing staff began to ambulate, the patient collapsed possibly from an embolism and died on (b)(6) 2012. Concomitant medications were not provided. The intensity for the event was severe. The reporting nurse did not provide any causal relationship between epicel and the event.
Patient Sequence No: 1, Text Type: D, B5
[10260719]
Manufacturer's comment: the benefit-risk relationship of epicel is not affected by this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00008 |
| MDR Report Key | 2850964 |
| Report Source | 05 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-11-11 |
| Date Mfgr Received | 2012-11-11 |
| Date Added to Maude | 2012-11-30 |
| 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 | 2012-11-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01638 |
| ID Number | UNK |
| Device Expiration Date | 2012-11-11 |
| 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 | 2012-11-21 |