MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-15 for EPICEL AU201 manufactured by Vericel Corporation.
[49646441]
This spontaneous report was received from a nurse via sales representative on 17-jun-2016, concerning a patient of an unknown age and sex who expired on (b)(6) 2016. The patient was grafted with (b)(4) units of cultured epidermal autografts (epicel) with lot number ee02058 for an unknown indication. Details regarding medical history and concomitant medication were not provided. On (b)(6) 2016, the patient was grafted with (b)(4) units of cultured epidermal autografts with lot number ee02058, product part number au201 and (b)(4). 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. 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.
Patient Sequence No: 1, Text Type: D, B5
[51495623]
Case description: this spontaneous report was received from a nurse via sales representative on 17-jun-2016, concerning a patient of an unknown age and sex who expired on (b)(6) 2016. The patient was grafted with 72 units of cultured epidermal autografts (epicel) with lot number ee02058 for an unknown indication. Details regarding medical history and concomitant medication were not provided. On (b)(6) 2016, the patient was grafted with 72 units of cultured epidermal autografts with lot number ee02058, product part number au201 and sales order number (b)(4). 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. 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. Additional information was received on 12-jul-2016 from the reporter concerning a (b)(6) years old female patient. The height and weight of the patient was reported as (b)(6). On (b)(6) 2016, the patient was hospitalized. Total body surface area (tbsa) burn was 70 percent. Medical information revealed no allergies to vancomycin, amikacin and amphoteracin b. On (b)(6) 2016, the biopsy was performed on left and right axilla and there was no wound or systemic infection of microbial and fungal origin. 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 72 grafts available for shipment interpretation was pass), dual stain assay (result: 50-75 percent interpretation was pass) and endotoxin assay as passed (result: less than 1). No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[65470372]
Multisystem organ failure. Case description: this spontaneous report was received from a nurse via sales representative on 17-jun-2016, concerning a patient of an unknown age and sex who expired on (b)(6) 2016. The patient was grafted with 72 units of cultured epidermal autografts (epicel) with lot number ee02058 for an unknown indication. Details regarding medical history and concomitant medication were not provided. On (b)(6) 2016, the patient was grafted with 72 units of cultured epidermal autografts with lot number ee02058, product part number au201 and sales order (b)(4). On (b)(6) 2016, the patient expired from an unknown cause. 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. 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. Additional information was received on 12-jul-2016 from the reporter concerning a (b)(6) female patient. The height and weight of the patient was reported as (b)(6) respectively. On (b)(6) 2016, the patient was hospitalized. Total body surface area (tbsa) burn was 70 percent. Medical information revealed no allergies to vancomycin, amikacin and amphoteracin b. On (b)(6) 2016, the biopsy was performed on left and right axilla and there was no wound or systemic infection of microbial and fungal origin. Qc sterility test results of pre-release sample type from (b)(6) 2016 and of final product sample type. On (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 72 grafts available for shipment interpretation was pass), dual stain assay (result: 50-75 percent interpretation was pass) and endotoxin assay as passed (result: less than no additional information was provided. Additional follow up information was received on 22-nov-2016 from a nurse. The nurse reported that the cause of death was multisystem organ failure. She also reported that the patient had a large burn and was very sick. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2016-00002 |
| MDR Report Key | 5798012 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-15 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-06-15 |
| Report Date | 2016-11-22 |
| Date Reported to Mfgr | 2016-11-22 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2016-07-15 |
| 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 GREKAS |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| Manufacturer City | CAMBRIDGE, MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6175885623 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| Manufacturer City | CAMBRIDGE, 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 | PFC |
| Date Received | 2016-07-15 |
| Model Number | AU201 |
| Lot Number | EE02058 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Hospitalization | 2016-07-15 |