MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-08-08 for PRIMATRIX, UNKNOWN SIZE/PRODUCT ID XXX-PRIMATRIX manufactured by Tei Biosciences Inc.
[51443318]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[51443319]
Per sus voluntary event report # mw5063247 patient reports having a skin graft (primatrix bovine) on front of the foot for almost a year and wound has not healed, is peeled off and is foul. It is separate at the graft level and patient still can make out the diamond pattern. Patient is worried about having a rejection issue with non-human products. No more information available.
Patient Sequence No: 1, Text Type: D, B5
[57606913]
Additional information was requested and on august 19, 2016 the following was received: according to the reporter (patient): "one year of healing, and starting over again. The picture shows a 1x1 1/2 patch was healed over but just popped of one night, you could see the crisscross pattern still on the back... It smelled horrible. " product id not provided. Integra has completed their internal investigation on august 23, 2016. The investigation included: methods: review of device history records. Review of complaints history. Results: product not returned so evaluation unable to be performed. Therefore, investigation for cause cannot be performed. Dhr review; unable to be reviewed as lot number was unavailable. Complaints history; including this complaint, there has been one complaint of this type out of (b)(4) units of this product line created in the last two years. This complaint is not adversely trending. Conclusion: root cause unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004170064-2016-00002 |
| MDR Report Key | 5854797 |
| Report Source | CONSUMER |
| Date Received | 2016-08-08 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-07-02 |
| Date Mfgr Received | 2016-09-13 |
| Date Added to Maude | 2016-08-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | TEI BIOSCIENCES INC |
| Manufacturer Street | 7 ELKINS STREET |
| Manufacturer City | BOSTON MA 02127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMATRIX, UNKNOWN SIZE/PRODUCT ID |
| Generic Name | PRIMATRIX |
| Product Code | KGN |
| Date Received | 2016-08-08 |
| Catalog Number | XXX-PRIMATRIX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEI BIOSCIENCES INC |
| Manufacturer Address | 7 ELKINS STREET 7 ELKINS STREET BOSTON MA 02127 US 02127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-08 |