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 2017-11-02 for EPICEL AU201 manufactured by Vericel Corporation.
[90900552]
Total number of grafts: 144.
Patient Sequence No: 1, Text Type: N, H10
[90900553]
This spontaneous report was received from a physician via a customer care representative on 06-oct-2017, concerning a (b)(6) male patient- (b)(6) who expired after being grafted with cultured epidermal autografts (epicel). The patient was grafted with 144 units of epicel with lot number ee01842 for 90% total body surface area (tbsa) full thickness burns. The relevant medical history included 90% total body surface thermal burns. Concomitant medication details were not reported. Allergies were ruled out to vancomycin, amikacin and amphotericin b. No other significant dermatology history reported. On (b)(6) 2014, the patient was injured and was hospitalized with 90% tbsa burn. On (b)(6) 2014 at 12:00 am, the biopsy was harvested from left groin and left lower abdomen. The patient had microbial wound infection (stenotrophomonas maltophilia, enterobacter cloacae, and klebsiella pneumoniae). It was reported that the patient underwent three grafting surgeries, i. E. On (b)(6) 2014 and in each time he was grafted with 48 units (a total of 144 grafts) of cultured epidermal autografts with lot numbers ee01842, ee01842a and ee01842b, respectively, for 90% tbsa full thickness burns. The product part number was au201 and the sale order number was not reported. Qc sterility test results of the pre-release sample and of final product sample type passed the quality control lot release assays. On 12-oct-2017, the quality control assay was reviewed which included qc2-027 graft inspection, qc2-094 dual stain, and qc2-010 endotoxin and these were interpreted as passed. The personnel monitoring of manufacturing passed in grade a and b parameters. The personnel monitoring of qc sterility passed in grade a parameters. On (b)(6) 2015, the patient expired due to an unspecified reason. Further details including description of clinical presentations, signs, symptoms, diagnostic tests, and baseline data, diagnosis, and autopsy results were not provided. The outcome was fatal. Action taken with epicel was not applicable. The reporter did not provide the causal relationship between death and epicel. Based on the limited information available on the possible cause of death, the company assessed the event of death as possibly related to epicel. Event will be reassessed on receipt of follow up information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2017-00009 |
| MDR Report Key | 6996783 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-06 |
| Date of Event | 2015-06-14 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-02 |
| 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 | MS. 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 | CULTURED EPIDERMAL AUTOGRAFTS (EPICEL) |
| Product Code | OCE |
| Date Received | 2017-11-02 |
| Model Number | AU201 |
| Lot Number | EE01842 |
| Device Expiration Date | 2015-06-14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | VERICEL CORPORATION 64 SIDNEY STREET CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-11-02 |