MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-13 for EPICEL AU201A manufactured by Vericel Coportation.
[144811184]
Quantity affected was 72 units. The assembly date was (b)(6) 2018. This case does not meet the criteria for reporting as an mdr. As per new pmsr combination product reporting guidance serious adverse events for combination products must also be reported.
Patient Sequence No: 1, Text Type: N, H10
[144811185]
Cardiac issue [cardiac disorder], pneumonia [pneumonia]. Case description: this spontaneous report was received from a physical therapist on 03-apr-2019 along with additional information on (b)(4) 2019 via a company representative, concerning an adult male patient of an unspecified race who expired after being grafted with cultured epidermal autografts (epicel). The patient was grafted with 72 units of epicel with lot number ee02272 for the thermal burn. The relevant medical history and concomitant medication details were not reported. The assembly date was reported as (b)(6) 2018. Biopsy details were not provided. It was reported that the patient had an epicel graft surgery on (b)(6) 2018 and was grafted with 72 units of cultured epidermal autografts with lot numbers ee02272 for the thermal burn. The product part number was au201a and the sale order number was (b)(4). 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 (b)(6) 2019, the patient expired due to unspecified cardiac issue and pneumonia. Further details including a description of clinical presentations, signs, symptoms, diagnostic tests, and baseline data, diagnosis, and autopsy results were not provided. The outcome of the events was fatal. The reporter assessed the causal relationship of the events, cardiac issue, pneumonia as not related to epicel. The company assessed the events of cardiac disorder and pneumonia as not related to epicel. This events did not meet the criteria for a mdr. Due to the events being assessed as serious and unexpected, as per the epicel package insert, this report will be expedited.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2019-00001 |
| MDR Report Key | 8603185 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-10 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-05-13 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY STREET |
| 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 | EPICEL CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2019-05-13 |
| Model Number | AU201A |
| Lot Number | EE02272 |
| Device Expiration Date | 2018-01-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL COPORTATION |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 2019-05-13 |