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).
[2721273]
Squamous cell carcinoma [squamous cell carcinoma]. Case description: spontaneous report was rec'd on (b)(6) 2012 from a physician via a company rep regarding a female pt, initials (b)(6). The pt's medical history was not provided. On an unspecified date the pt was grafted with epicel (number of grafts and location unspecified). On an unspecified date, the pt developed squamous cell carcinoma. The pt's event was medically significant. The action taken with epicel treatment was not provided. The outcome for the event of squamous cell carcinoma was not provided. Concomitant medications were not provided. The intensity for the event of squamous cell carcinoma was not provided. The relationship between epicel and the event of squamous cell carcinoma was not provided by the rptr. Add'l info was rec'd on (b)(6) 2012 from the physician via the company rep. The pt was grafted with epicel in 1997.
Patient Sequence No: 1, Text Type: D, B5
[9860804]
Add'l info was rec'd on (b)(6) 2012 in the form of qa results. Eval summary: the product lot number was not provided; therefore a batch record review is not possible. It is the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result is identified and mitigated. Data is periodically presented and reviewed by individuals responsible for assuring product quality. This review has not indicated trends that could be associated with any product complaint. Genzyme will continue to monitor complaints. (b)(4). 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 | 1226230-2012-00002 |
| MDR Report Key | 2574015 |
| 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 KINDELL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177689000 |
| 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 | 2012-05-07 |
| 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. Other | 2012-05-07 |