MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-06 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[4518819]
This unsolicited device case from united states was initially received on (b)(4) 2014 as a product complaint. After further investigation, it was determined to meet criteria for a device event (malfunction) on (b)(6) 2014. This case concerns a(b)(6) year old male pt who was grafted with epicel (cultured epidermal autografts) that failed to adhere to the pt's wound beds (device malfunction). It was reported that the pt was not allergic to vancomycin, amikacin, amphotericin b. No medical history, past drugs, concomitant medications and concurrent conditions were reported. On (b)(6) 2014, the pt sustained 85 percent of total body surface area (tbsa) thermal burns and the same day pt was admitted to the hosp. On (b)(6) 2014 (at 14:40 hours), the pt's biopsy samples were taken from the right and left groin area. On (b)(6) 2014, the pt underwent a third grafting operation with epicel (previous grafts on (b)(6) 2014). A total of 70 grafts had been cultured for the current operation (batch/lot#: ee01781). However, 37 grafts were discarded upon receipt at the hosp because, after visual inspection by the sales rep, they were found to be scalloping, peeled off from the gauze, or floating from the gauze. There were no issues reported with the surgical clips holding the grafts to the gauze. The remaining 33 grafts were fragmented, but considered usable and these grafts were placed on prepared wound beds at unspecified locations of the body. On (b)(6) 2014, it was reported that none of the 33 grafts had taken. No clinical adverse events were reported. The case was considered by the company to be a device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[11969840]
The review of the lot batch records, supporting documentation, and testing results indicate that the lot met all in-process and release specs. The courier confirmed that standard procedures for transporting lot ee01781 had been followed and the courier did not encounter any issues with the transport boxed. Two probable root causes were determined. The first probable root cause is that the cells were not banked early enough to slow down growth as the lot reached 100% confluency two days prior to the graft and the lot was banked one day prior to graft. The second probable root cause is that a high cell inoculation density was selected which caused the cells to reach 100% confluency prior to grafting. The appropriate personnel were made aware of the importance of properly reviewing the lot observation logs to make informed decision on cell inoculation density and the need to bank cultures prior to grafting. Epicel lots are pt specific. No other product events have been identified for this lot; therefore, no trend has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2014-70773 |
| MDR Report Key | 3919726 |
| Report Source | 05 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-04-09 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-07-23 |
| 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 Contact | MICHAEL MURPHY |
| Manufacturer Street | 55 COPORATE DR MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089813633 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | CULUTRED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2014-06-06 |
| Lot Number | EE01781 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Required No Informationntervention | 2014-06-06 |