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 .
[1418736]
On (b)(6) 2009, a (b)(6) female had left breast reconstruction with a tissue expander and dermal graft and was released the next day. On or about (b)(6) 2009, the pt developed signs of an infection, which are described as "the left breast was red and swollen. " she is also described as having a temperature of 103 degrees f. The pt was re-admitted to the hospital and treatment prescribed as iv antibiotics (oxacillin) and removal of the implant and tissue expander on (b)(6) 2009. On (b)(6) 2009, the wound site cultures were taken and grew (b)(6). The pt was also noted to have a wbc of 19,000. The pt was released from the hospital on (b)(6) 2009 and as of (b)(6) 2009, the pt's status is "improving and awaiting second reconstruction. " 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
[8431059]
Serial number was received on december 4, 2009, and with this investigation could begin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001236616-2009-00051 |
| MDR Report Key | 1570664 |
| Report Source | 05,06 |
| Date Received | 2010-01-06 |
| Date of Report | 2009-12-15 |
| Date of Event | 2009-10-22 |
| 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 | 0030900634 |
| ID Number | 1006A FOR TISSUE CODE 471616 |
| Device Expiration Date | 2012-06-15 |
| 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 |