MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-07 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[2714987]
Squamous cell carcinoma [squamous cell carcinoma]. Case description: spontaneous report was received on (b)(6) 2012 from a physician via a company rep regarding a pt (gender not provided), initials - (b)(6). The pt received epicel an unk number of times. The outcome of the pt is fatal. On an unspecified date, the pt was grafted with epicel. The epicel lot number was not provided. On an unspecified date, the pt developed squamous cell carcinoma. The intensity for the event of squamous cell carcinoma was not provided. Relevant concomitant medications were not provided. The relationship between epicel and the event of squamous cell carcinoma was not provided. (b)(4). Additional info was received on (b)(6) 2012 from a physician via a company rep. The pt was male, initials (b)(6), in 1993, the pt was grafted with epicel. On an unspecified date, the pt expired. No further info available at this time.
Patient Sequence No: 1, Text Type: D, B5
[9861253]
Qa investigation results were received on (b)(6) 2012. Eval summary: this event is currently not linked to a pt lot number, so qa is unable to perform an investigation including a batch record review and a review of the qc sterility and em data (since all data is linked to pt lot number). Because of the serious nature of this event qa will leave this record open until pv indicates all efforts have been exhausted in determination of the pt lot number. Manufacturer's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00003 |
| MDR Report Key | 2574046 |
| Report Source | 05,07 |
| Date Received | 2012-05-07 |
| Date of Report | 2012-04-26 |
| Date Mfgr Received | 2012-04-26 |
| Date Added to Maude | 2012-05-16 |
| 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 | JILL ROBINSON, R. PH, MBA |
| Manufacturer Street | 675 WEST KENDALL ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177689000 |
| 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 | 2012-05-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2012-05-07 |