MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for EPICEL manufactured by Vericel Corporation.
[48156910]
This spontaneous report was received from a nurse on (b)(6) 2016, concerning a patient of unknown age and sex who expired on (b)(6) 2016. The patient was previously grafted with 15 units of cultured epidermal autografts (epicel) with lot number ee02023 for an unknown indication on (b)(6) 2016. Details regarding medical history and concomitant medication were not provided. On (b)(6) 2016, the patient was grafted with 15 units of cultured epidermal autografts with lot number ee02023. On (b)(6) 2016, the patient expired from an unknown cause. Details regarding treatment was not provided. This is a test case!
Patient Sequence No: 1, Text Type: D, B5
[53055250]
This spontaneous report was received from a nurse on 25-apr-2016, concerning a patient of unknown age and sex who expired on (b)(6) 2016. The patient was previously grafted with 15 units of cultured epidermal autografts (epicel) with lot number ee02023 for an unknown indication on (b)(6) 2016. Details regarding medical history and concomitant medication were not provided. On (b)(6) 2016, the patient was grafted with 15 units of cultured epidermal autografts with lot number ee02023. On (b)(6) 2016, the patient expired from an unknown cause. Details regarding treatment was not provided. Further details including description of clinical presentation, signs, symptoms, diagnostic tests, baseline data, diagnosis, cause of death and autopsy results were not reported. Qc sterility test results of pre-release sample type from (b)(6) 2016 and of final product sample type (b)(6) 2016 were both negative. Environmental results: personnel monitoring of manufacturing passed in grade a and b parameters and personnel monitoring of qc sterility passed with grade a parameters. The quality control assay were reviewed which included graft inspection (results were 15 grafts available for shipment interpretation was pass), dual stain assay (result :50-75 percent viable) and endotoxin assay as passed (result: less than 1). Outcome: fatal. Seriousness criterion: death. The reporter did not provide the causal relationship between the event and epicel grafts. However, as per the condition of the humanitarian device exemption, that "unless death is specifically reported as "not related" to epicel by the reporter, it will be considered causally related", this event is considered as related to epicel grafts. Company comments: based on the initial information received the event is considered as possibly related to the epicel graft. The case will be reassessed on receipt of further information. Additional information was received on 13-jul-2016 from a reporter concerning an 8 year old female patient. The height and weight of the patient was reported as (b)(6) respectively. On (b)(6) 2016, the patient was injured. The total body surface area (tbsa) burn was 85. 5 percent. Medical information revealed no allergies to vancomycin, amikacin and amphotericin b. On (b)(6) 2016, biopsy was performed on left and right buttock however results were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2016-00001 |
| MDR Report Key | 5745687 |
| Date Received | 2016-06-23 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-04-25 |
| Report Date | 2016-04-25 |
| Date Reported to Mfgr | 2016-04-25 |
| Date Mfgr Received | 2016-07-13 |
| Date Added to Maude | 2016-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LIZ BICCHIERI |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| Manufacturer City | MA MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6175885623 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| Manufacturer City | 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 |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2016-06-23 |
| Lot Number | EE02023 |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE MA MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-06-23 |