MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2013-10-16 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[3882401]
Spontaneous report was received on (b)(6) 2012 from a consumer via a company rep regarding a pt whose initials, date of birth, and gender were not provided. On (b)(6) 2012, the pt was grafted with epicel. On (b)(6) 2012, the pt's next of kin contacted the company's customer care service to report that the pt expired "after being grafted" (exact date not provided). The epicel lot number was ee01541. The number of grafts was not provided. Concomitant medications were not provided. The relationship between epicel and the event of death was not provided by the reporter. Follow-up info was received on (b)(6) 2012 from the physician in the form of the pt's biopsy transmittal. The following pt identifying info was provided: initials: (b)(6), date of birth: (b)(6) 1994, height: (b)(6) and weight: (b)(6). On (b)(6) 2011, the pt experienced 99% total body surface area thermal burns and was admitted to the hospital on the same day. The pt's biopsy samples were taken on (b)(6) 2011 from the left groin, and left axilla. Follow-up info was received on (b)(6) 2012 in the form of an investigation summary. Pt lot# ee01541 was received as a biopsy, but was not completed as a graft assembly because incoming biopsy material was contaminated. An additional biopsy was received from same pt, but the new biopsy material received a different lot number: epicel lot number ee01561. Lot# ee01561 was successfully assembled and grafted on pt. At the point of notification of pt expiry, a product event was initiated for this pt ((b)(6)), product intake number (b)(4), and a qa investigation was completed. No investigation can be completed for ee01541, because the lot was not processed to completion at our facility and was never sent to pt. Product event referencing lot# ee01561 (product event# (b)(4)) should be referenced for this product event, because ee01561 resulted in a shipment to pt, but ee01541 did not. Follow-up info was received on (b)(6) 2013 from the physician in the form of the pt's biopsy transmittal with reporter info and clinical course. The pt had experienced 97% total body suface area flame burns (earlier reported as 99%). The pt's biopsy samples were taken on (b)(6) 2011 (at 12:27) from the sacrum and from an unk site. The samples from the unk site revealed microbial and fungal infection. It was reported that the pt received topical amphotericin (amphotericin b) and eraxis and systemic primaxin (imipenem), zosyn (piperacillin sodium; tazobactam sodium), vancomycin, gabapentin and fluoxetine. While processing the follow up with (b)(6) on (b)(6) 2013, it was realized that the date of engraftment of epicel was incorrectly captured as (b)(6) 2012 instead of (b)(6) 2011. Follow-up info was received on (b)(6) 2013 from the physician regarding the pt's clinical course. On unspecified dates, the pt developed septic shock, multi system organ failure and cardiopulmonary arrest. On (b)(6) 2011, the pt died due to septic shock, multi system organ failure and cardio-pulmonary arrest. It was reported that autopsy was performed but results were not provided because the physician needed to have the consent from pt's parent or executor of estate. The reporting physician assessed the relationship of epicel with the event of thermal burn as unrelated and did not provide the relationship of epicel with the events of septic sock, multi system organ failure and cardio-pulmonary arrest.
Patient Sequence No: 1, Text Type: D, B5
[11155799]
Pma/510(k): hde 990002. Pharmacovigilance comment: mfr's comment: the benefit-risk relationship of epicel is not affected by this report. Sanofi company follow-up comment dated (b)(4) 2013: this case concerns a pt who died of thermal burn and cardiopulmonary arrest after engraftment of epicel. Thermal burns itself is a significant morbidity agent, hence causality cannot be denied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2013-00002 |
| MDR Report Key | 3421961 |
| Report Source | 04,05,07 |
| Date Received | 2013-10-16 |
| Date of Report | 2012-06-04 |
| Date Mfgr Received | 2013-10-09 |
| Date Added to Maude | 2013-10-22 |
| 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 DIRVE MS: 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 | 2013-10-16 |
| Lot Number | EE01561 |
| 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; 2. Hospitalization | 2013-10-16 |