MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-25 for FLEXHD-8CM X 20CM/MTF - HUMAN ALLOGRAFT manufactured by .
[1753504]
The patient underwent bilateral breast reconstruction surgery with tissue expanders, and was implanted with the flexhd allograft. On or about (b)(6) 2010, she returned to the surgeon's office for a follow-up visit. It was reported that the wound site "had broken down and contained fluid". The surgeon obtained cultures of the fluid around the wound site and from under the mastectomy flaps. A sample of the flexhd tissue was also cultured. The cultures were positive for (b)(6). Additional information has been requested; not yet received. Dose, frequency & route used: single use, 064. Therapy dates: (b)(6) 2010. Diagnosis for use: soft tissue repair.
Patient Sequence No: 1, Text Type: D, B5
[8742631]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001236616-2010-00023 |
| MDR Report Key | 1882423 |
| Report Source | 05,06 |
| Date Received | 2010-10-25 |
| Date of Report | 2010-07-26 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-07-21 |
| Date Added to Maude | 2010-10-29 |
| 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 | SHARON BOLDS |
| Manufacturer Street | 125 MAY ST, STE 300 |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326612337 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXHD-8CM X 20CM/MTF - HUMAN ALLOGRAFT |
| Generic Name | NONE |
| Product Code | LMO |
| Date Received | 2010-10-25 |
| Lot Number | 1003A |
| ID Number | 0650903397 |
| Device Expiration Date | 2010-07-16 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-25 |