MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for FLEXHD, 6CM X 16CM/MTF - HUMAN ALLOGRAFT 47616 manufactured by .
[19842845]
On (b)(6) 2010, the patient underwent a bilateral simple mastectomy and bilateral axillary node dissection with tissue expander insertion and was implanted with 2 dermal allografts. She was discharged on (b)(6) 2010. In (b)(6), 2011, the patient presented with fluid collection/leakage and wound dehiscence. On (b)(6) 2011, she was re-admitted for removal of the tissue expander with replacement. Cultures were obtained and were reported as 'no growth'. The patient was treated with bactrim and is recovering. Note: this is the first of 5 alleged post-operative infections (different patients/different donors) received from this facility in a single report. Allograft serial number(s) and incident details were not provided until (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001236616-2011-00018 |
| MDR Report Key | 2177018 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2011-07-11 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-06-15 |
| Date Added to Maude | 2011-07-26 |
| 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 | NINA ONYSZCZUK |
| Manufacturer Street | 125 MAY STREET SUITE 300 |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326614064 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXHD, 6CM X 16CM/MTF - HUMAN ALLOGRAFT |
| Generic Name | NONE |
| Product Code | LMO |
| Date Received | 2011-07-22 |
| Catalog Number | 47616 |
| Lot Number | 0350907565 |
| ID Number | 1021A |
| Device Expiration Date | 2012-10-30 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2011-07-22 |