MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-23 for PRIMATRIX 607-005-440 manufactured by Tei Biosciences Inc..
[17210425]
The pt had the device implanted during surgery on (b)(6) 2015. A pico wound vac device was also used on the wound. On (b)(6) 2015 the pt presented with large area of blanching around the wound in a circle. There was no pt discomfort, odor nor was the area tender. The would was debrided and after one week the inflammation was not visibly present. Subsequent to device removal, another collage-based wound device was placed and gave a similar type of reaction. It is probable that the pt's condition (sensitivity to collagen) caused the device to fail. The device instructions for use caution against use of the device in pts with a sensitivity to collagen.
Patient Sequence No: 1, Text Type: D, B5
[17425567]
The device history record for this device was reviewed and everything was in order.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004170064-2015-00002 |
| MDR Report Key | 4867745 |
| Report Source | 07 |
| Date Received | 2015-06-23 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-04-06 |
| Device Manufacturer Date | 2015-02-26 |
| Date Added to Maude | 2015-06-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT BUEHLER |
| Manufacturer Street | 7 ELKINS ST. |
| Manufacturer City | BOSTON MA 02127 |
| Manufacturer Country | US |
| Manufacturer Postal | 02127 |
| Manufacturer Phone | 6172681616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMATRIX |
| Generic Name | WOUND COVER |
| Product Code | KGN |
| Date Received | 2015-06-23 |
| Model Number | 607-005-440 |
| Lot Number | 1501023 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEI BIOSCIENCES INC. |
| Manufacturer Address | BOSTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-23 |