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 471616 manufactured by .
[2121946]
On (b)(6) 2011, the pt underwent a bilateral simple mastectomy and tissue expander insertion, was implanted with the allograft, and discharged on (b)(6) 2011. On (b)(6) 2011, she presented with cellulitis and swelling at the surgical site. Cultures obtained on (b)(6) 2011 grew (b)(6). The pt was re-admitted on (b)(6) 2011 for removal of the right breast tissue expander and allograft, abscess cavity evacuation, and was discharged on (b)(6) 2011. Iv and oral antibiotics were prescribed. The pt is recovering. Note: allograft serial number and incident details were not provided until (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001236616-2011-00021 |
| MDR Report Key | 2177016 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2011-07-11 |
| Date of Event | 2011-04-26 |
| 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 STE 300 |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326614064 |
| Single Use | 3 |
| 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 | 471616 |
| Lot Number | 0021003909 |
| ID Number | 1005A |
| Device Expiration Date | 2014-01-19 |
| 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 |