MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-08-21 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFTS UNK manufactured by Genzyme Biosurgery (cambridge).
[15506814]
Cardiovascular failure [cardiac failure]. Case description: spontaneous report was received on (b)(6) 2012, from a physician (via a company rep) regarding a pt (initials, date of birth, and gender not provided). The pt's medical history was not provided. The pt was grafted with epicel on two occasions, 96 grafts on (b)(6) 2011, and 40 grafts on (b)(6) 2012. On (b)(6) 2012, the pt expired due to cardiovascular failure. The action taken with epicel treatment was not provided. Concomitant medications were not provided. The intensity for the event of cardiovascular failure was not provided. The relationship between epicel and the event of cardiovascular failure was assessed as unrelated by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
[15622302]
Additional info was received on (b)(4) 2012, in the form of qa investigation summary. All sterility and environmental monitoring results for the production of the epicel assemblies for lot ee01572 met acceptance criteria. Qa's review the lot batch records, supporting documentation, and testing results indicate that lot ee01572 met all in-process and release specifications. The benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00004 |
| MDR Report Key | 2713656 |
| Report Source | 05,07 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-01-31 |
| Date Mfgr Received | 2012-01-31 |
| Date Added to Maude | 2012-08-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL ROBINSON R., PH, MBA |
| Manufacturer Street | 675 W. KENDALL ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177689000 |
| Manufacturer G1 | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Street | 64 SIDNEY ST. |
| 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 (CULTURED EPIDERMAL AUTOGRAFTS) GRAFTS |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2012-08-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01572 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Address | CAMBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-08-21 |