MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2010-10-25 for FLEX HD, HUMAN ALLOGRAFT manufactured by .
[1739047]
On (b)(6) 2010, a (b)(4) female patient had what is described as "bilateral mastectomies with first stage reconstruction with tissue expanders. " on (b)(6) 2010, the patient developed signs of an infection of the left breast: cellulitis, seroma, and a fever of 102 degrees fahrenheit. The patient was treated with ciprofloxacin. On (b)(6) 2010, cultures of the fluid were taken and grew (b)(6). As of (b)(6) 2010, the patient is listed as "improved". Dose, frequency & route used: single use, 64. Therapy dates: (b)(6) 2010. Diagnosis for use: soft tissue repair.
Patient Sequence No: 1, Text Type: D, B5
[8855677]
Additional lot #0030905637. Additional exp. Date: 01/22/2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001236616-2010-00021 |
| MDR Report Key | 1882398 |
| Report Source | 05,06,08 |
| Date Received | 2010-10-25 |
| Date of Report | 2010-06-25 |
| Date of Event | 2010-04-29 |
| Date Mfgr Received | 2010-06-11 |
| 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 | FLEX HD, HUMAN ALLOGRAFT |
| Generic Name | NONE |
| Product Code | LMO |
| Date Received | 2010-10-25 |
| Lot Number | 0650902526 |
| Device Expiration Date | 2013-03-04 |
| 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. Other | 2010-10-25 |