MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-05 for EPICEL manufactured by Vericel Corporation.
[123053339]
Product part number: au201. Sales order number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123053340]
Event verbatim [preferred term] (related symptoms if any separated by commas). Relevant tests/laboratory data, including dates. Other relevant history, including preexisting medical conditions (e. G. Allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc. ) (b)(6) 2018. Case description: this initial spontaneous report was received from a physician on 10-jul-2018 along with additional information on 13-jul-2018 and 19-jun-2018 via a company representative and concerns a male patient of an unspecified age and race who was grafted with cultured epidermal autografts (epicel). The patient was initially grafted with 96 grafts of epicel on (b)(6) 2018 followed by 44 grafts of epicel on (b)(6) 2018, with lot number ee02280. Other relevant medical history was not provided. The product part number was reported as au201 and sales order numbers were (b)(4). The quantity affected was reported as 140. The date of assembly was reported as (b)(6) 2018. The patient was implanted with epicel on (b)(6) 2018. The qc sterility test was performed and results of pre-release sample type (b)(4) was passed and sterility test results of final product sample type (b)(4) were also reported as passed. Environmental results included personal monitoring of manufacturing which had passed with grade a and b parameters and personnel monitoring of qc sterility which had passed with grade a parameters. The quality control assay was reviewed which included (b)(4) graft inspection, (b)(4) dual stain assay, and (b)(4) endotoxin assay, all were reported as passed. On an unspecified date the patient experienced sepsis. On an unspecified date after receiving epicel implants, the patient had expired. Action taken with epicel was not applicable. The causality was reported as not related to epicel. Additional information was received on 07-sep-2018, the demography of the patient was reported (b)(6) year-old male. On (b)(6) 2017, at 08:26 pm the biopsy was harvested. The assembly date was unspecified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2018-00001 |
| MDR Report Key | 7938313 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-05 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-10-05 |
| 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 |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6175885623 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | EPICEL CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2018-10-05 |
| Lot Number | EE02280 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | CAMBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-10-05 |