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 |