MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2013-05-08 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[3504069]
Device malfunction [device malfunction]. Case description: spontaneous report was received on (b)(6) 2013 from a physician regarding a (b)(6) female patient, initials (b)(6). The patient's medical history was not provided. On (b)(6) 2013, the patient sustained 35% total body surface area (tbsa) burns (cause unknown) and was hospitalized the same day. On (b)(6) 2013, two biopsies were taken for cell culture and harvesting from lower abdomen and left groin of the patient. On (b)(6) 2013, the patient was grafted with an unknown number of epicel grafts at unspecified sites. On (b)(6) 2013, the final product sterility and retain samples returned positive for contamination with yeast (candida parapsilosis) post implant which could have been contamination at the time of procurement, as per qa (device malfunction). It was reported that the patient was clinically stable with no sign of infection and no complication. The graft take as per the surgeon was excellent at 90%. The event outcome is unknown. Relevant concomitant medications included augmentin (clavulanic acid), silver dressings and amphotericin (amphotericin b). The relationship between epicel and the event was not provided by the reporting physician.
Patient Sequence No: 1, Text Type: D, B5
[10707032]
Manufacturer's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2013-00001 |
| MDR Report Key | 3115632 |
| Report Source | 00,01,05 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-04-28 |
| Date Mfgr Received | 2013-04-28 |
| Date Added to Maude | 2013-05-31 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL ST. |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| 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) GRAFT |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | MGR |
| Date Received | 2013-05-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01705 |
| 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. Other | 2013-05-08 |