MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-20 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[18812968]
This unsolicited device case from united states was rec'd on (b)(4) 2014 from a non-healthcare professional. This case concerns a female patient (age not provided) who had complicated post procedural course, did not feel well, was non-responsive and died following grafting with epicel cultured epidermal autografts (epicel). No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported. On (b)(6) 2013, the patient was grafted with epicel cultured epidermal autografts (batch/lot number ee01702 and ee01702a; and expiration date of biopsy transport media: unknown; number of grafts not provided) on an unspecified location for thermal burn. On (b)(6) 2013, the patient was again grafted with epicel cultured epidermal autografts (batch/lot number ee01702 and ee01702a and expiration date: unknown; number of grafts not provided). It was reported that the patient had a long complicated course but finally recovered and went to rehabilitation. It was also reported that the patient had gone home and began doing very well. On unknown dates in 2013, few days after grafting, the patient did not feel well for few days when her mother found her unresponsive and was unable to revive her. On (b)(6) 2014 (after 10 months of grafting), patient died of an unknown cause. The sterility and environmental monitoring results were rec'd. All sterility results for the production of epicel lot ee01702 were negative for contamination. On an unknown date, the autopsy was performed which did not establish the cause of death. Corrective treatment: not reported. Outcome: unknown for non-responsive and not been feeling well; recovered for complicated course. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5
[19096505]
(b)(4). Pharmacovigilance comment: sanofi company comment date (b)(4) 2014: this case concerns a patient who was found unresponsive after treatment with epicel. Although the role of epicel cannot be excluded for the occurrence of the event, however, the lack of info regarding concomitant medications used by the patient precludes the complete case assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2014-18131 |
| MDR Report Key | 3678618 |
| Report Source | 04 |
| Date Received | 2014-02-20 |
| Date of Report | 2014-02-06 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2014-02-06 |
| Date Added to Maude | 2014-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 55 CORPORATE DRIVE, MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089816698 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2014-02-20 |
| Lot Number | EE01702, EE01702A |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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; 2. Other | 2014-02-20 |