MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-12 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[4117073]
This unsolicited device case from united states received on (b)(6) 2013 from a physician. This case concerns a patient (demographics not provided) who had some metabolic disturbances, suffered from (03) strokes and patient passed away after receiving epicel cultured epidermal autografts (epicel). Relevant medical history, concomitant conditions or medications were not provided. On (b)(6) (year unspecified), the patient received epicel cultured epidermal autografts (route, dosage regimen, batch/lot number : (b)(4) and expiration date unknown) into an unspecified location for thermal burns. On an unspecified date, the patient passed away due to unreported cause. It was reported that the patient was essentially healed and was being worked for some reconstruction and touch up grafting. On an unspecified date, magnetic resonance imaging (mri) showed that the patient had 03 strokes and had some metabolic disturbances. Corrective treatment: not reported. Outcome: unknown for the events of some metabolic disturbances and suffered from 03 strokes. Fatal for the event of passed away. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criteria: suffered from 03 strokes: important medical event as per ime list. Passed away: patient died.
Patient Sequence No: 1, Text Type: D, B5
[11453379]
Pharmacovigilance comment: sanofi company comment dated (b)(4) 2013: in this case, the causal role of the epicel cannot be excluded for the occurrence of the event of stroke and the fatal event of death nos; however, the lack of information regarding the underlying medical history and the concomitant medications used by the patient precludes the complete case assessment, and moreover the lack of information regarding the autopsy findings of the patient and the further information lack regarding the autopsy details precludes the complete case assessment. Initial reporter: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2013-28598 |
| MDR Report Key | 3535578 |
| Report Source | 05 |
| Date Received | 2013-12-12 |
| Date of Report | 2013-12-06 |
| Date Mfgr Received | 2013-12-06 |
| Date Added to Maude | 2013-12-26 |
| 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 | BRIDGEWATE 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 AUTOGRAPHS |
| Product Code | OCE |
| Date Received | 2013-12-12 |
| Lot Number | EE01741 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-12-12 |