MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-06 for FLEX HD, HUMAN ALLOGRAFT manufactured by .
[1418737]
On (b)(6) 2009, a (b)(6) female with a history of undergoing chemotherapy had right breast reconstruction with a tissue expander and dermal graft and was released the next day. She had one previous surgery at this site. On (b)(6) 2009, the pt develop signs of an infection, which are described as "red, swollen, and fluctuant. " there was no sign of fever or elevated white blood cells. She was readmitted to the hospital on (b)(6) 2009, and the treatment prescribed was treatment with antibiotics and removal of the graft and tissue expander. On (b)(6) 2009, wound site cultures were taken and grew (b)(6). The pt was released from the hospital on (b)(6) 2009, and as of (b)(6) 2009, the pt is listed as "improving. " dose, frequency and route used: single use, 64. Therapy dates: (b)(6) 2009; (b)(6) 2009. Diagnosis for use: soft tissue repair.
Patient Sequence No: 1, Text Type: D, B5
[8431060]
Serial number was received on december 4, 2009, and with this, the investigation could begin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001236616-2009-00050 |
| MDR Report Key | 1570668 |
| Report Source | 05,06 |
| Date Received | 2010-01-06 |
| Date of Report | 2009-12-15 |
| Date of Event | 2009-06-25 |
| Date Mfgr Received | 2009-11-20 |
| Date Added to Maude | 2010-09-30 |
| 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 | FLEX HD, HUMAN ALLOGRAFT |
| Generic Name | NA |
| Product Code | LMO |
| Date Received | 2010-01-06 |
| Lot Number | 00295079 |
| ID Number | 1108A FOR TISSUE CODE 471816 |
| Device Expiration Date | 2001-04-04 |
| 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. Required No Informationntervention | 2010-01-06 |