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 2017-07-19 for EPICEL AU201 manufactured by Vericel Corporation.
[80456555]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[80456556]
Patient expired [death]. Case description: this spontaneous report this spontaneous report was received from a physician on (b)(6) 2017, along with additional information on (b)(6) 2017, concerning a (b)(6) male patient, who expired on (b)(6) 2017, following grafting with 48 epicel cultured epidermal autografts (epicel) with lot number ee02184a, for thermal burn. Medical history and relevant concomitant medication details were not reported. On (b)(6) 2017, a (b)(6) patient was injured with 4th and 3rd degree, 95% of total body surface area burn (tbsa) on chest, abdomen, bilateral arms, bilateral limbs and legs and he was admitted to the hospital on the same date. On (b)(6) 2017, the biopsy was taken from right and left groin. The patient received sulfaderm cream as a treatment. On (b)(6) 2017, the patient received 48 grafts of epicel. The product part number was reported as au201 and sales order number was (b)(4). The quantity affected was reported as 48. The date of assembly was reported as (b)(6) 2017. On (b)(6) 2017, the patient expired. The product was not returned to the manufacture. Autopsy details were not provided. Therapeutic measures were not provided. Qc sterility test was performed on an unspecified date in 2017 and the results of pre-release sample type from (b)(6) 2017 and of final product sample type from (b)(6) 2017 were both negative. Environmental results included personnel monitoring of manufacturing which had passed both with grade a and b parameters and personnel monitoring of qc sterility which had passed with grade a parameters on an unspecified date in 2017. The quality control assay reviewed in 2017 included qc2-027 graft inspection as passed, qc2-094 dual stain assay as passed and qc2-010 endotoxin assay was also passed in 2017. The reporter's causality between the event and epicel grafts was not reported. The company assessed the causality of event death as possibly related due to limited information provided. The causality will be reassessed on receipt of follow up information. Additional information have been requested and the same will be updated upon receipt.
Patient Sequence No: 1, Text Type: D, B5
[85933376]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85933377]
This spontaneous report was received from a physician on (b)(4) 2017, along with additional information on 17-jul-2017, concerning a (b)(6)-year-old male patient, who expired on (b)(6) 2017, 36 days after grafting with 48 units of epicel (cultured epidermal autografts) with lot number ee02184a, for thermal burn. Medical history and relevant concomitant medication details were not reported. On (b)(6) 2017, a (b)(6) year-old patient was injured with a 4th and 3rd degree, 95% of total body surface area burn (tbsa) on chest, abdomen, bilateral arms, bilateral limbs and legs and he was admitted to the hospital on the same date. On (b)(6) 2017, the biopsy was taken from the right and left groin. The patient received sulfaderm cream as a treatment. On (b)(6) 2017, the patient received 48 grafts of epicel. The product part number was reported as au201 and sales order number was (b)(4). The quantity affected was reported as (b)(4). The date of assembly was reported as (b)(6) 2017. On (b)(6) 2017, 36 days after receiving epicel grafts, the patient expired. The product was not returned to the manufacturer. Autopsy details were not provided. Therapeutic measures were not provided. Qc sterility test was performed on an unspecified date in 2017 and the results of pre-release sample type from (b)(6) 2017 and of final product sample type from (b)(6) 2017 were both negative. Environmental results included personnel monitoring of manufacturing which had passed both with grade a and b parameters and personnel monitoring of qc sterility which had passed with grade a parameters on an unspecified date in 2017. The quality control assay reviewed in 2017 included (b)(4) graft inspection as passed, (b)(4) dual stain assay as passed and (b)(4) endotoxin assay was also passed in 2017. The reporter's causality between the event and epicel grafts was not reported. The company assessed the causality of event death as possibly related due to the limited information provided. The causality will be reassessed on receipt of follow up information. Additional information has been requested and the same will be updated upon receipt. Additional information was received on 15-aug-2017, per the treating physician. The patient with 95% tbsa, had epicel placed and the physician reported that the graft take was excellent. The areas the product was applied healed without concern. The patient, unfortunately, died of sepsis and systemic infection due to aspergillus in his lungs and the infection on his back (unspecified). Per the reporter, the patient's death was due to the burn. The reporter's causality between the event and epicel was reported as not related. The company assessed the events of aspergillus infection and sepsis not related to epicel, as the events of sepsis and the aspergillus infection were caused by the patient's burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2017-00007 |
| MDR Report Key | 6725251 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-07-19 |
| 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 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 | EPICEL |
| Product Code | OCE |
| Date Received | 2017-07-19 |
| Model Number | AU201 |
| Lot Number | EE02184A |
| Device Expiration Date | 2017-12-07 |
| Device Availability | * |
| 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 CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-07-19 |