MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for HP TISSUE MATRIX HPTM 08161097 manufactured by Lifecell.
[46889453]
Developed a staph infection of either the breast expander or the hptm by lifecell. I noticed in my record that the dermal matrix was in trial. I did not give any permissions to be in a trial. Dermal matrix and implants were removed due to a staph infection (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062726 |
| MDR Report Key | 5707009 |
| Date Received | 2016-06-01 |
| Date of Report | 2016-06-01 |
| Date of Event | 2015-08-05 |
| Date Added to Maude | 2016-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HP TISSUE MATRIX |
| Generic Name | HP TISSUE MATRIX |
| Product Code | OXH |
| Date Received | 2016-06-01 |
| Model Number | HPTM |
| Catalog Number | 08161097 |
| Lot Number | UP100005-026 |
| Device Expiration Date | 2015-09-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFECELL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-06-01 |