MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for PRIMATRIX, UNKNOWN SIZE/PRODUCT ID XXX-PRIMATRIX manufactured by Tei Biosciences Inc.
[75718295]
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
[75718296]
One of 2 reports - other mfg report number: 3004170064-2017-00002. It was reported by the patient, an uncomfortable feeling with primatrix in left leg. Appears hard, rock like and square shape imprint. Remains implanted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[83361802]
Integra has completed their internal investigation on june 7, 2017. Results: device has been implanted and will not be returned for evaluation, therefore failure analysis cannot be performed. Dhr review; lot number not specified, therefore dhr review cannot be completed. Complaints history; complaint occurrence rate: one complaint of (b)(4) units sold from april 2016-april 2017 results in an occurrence rate of (b)(4). Conclusion: device has been implanted and will not be returned for evaluation, therefore root cause analysis cannot be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004170064-2017-00006 |
| MDR Report Key | 6583287 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-04-27 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-05-22 |
| 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 | 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 | 2017-05-22 |
| 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 | 2017-05-22 |