MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-19 for PRIMATRIX 4CM X 4CM 607-001-440 manufactured by Tei Biosciences Inc.
[77862578]
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
[77862579]
It was reported that the patient had an allergic reaction (hives) around the site where primatrix was placed. The patient has a pressure ulcer on right ischium, stage 4 (since 2013). Dressings used were as follows; steri strips, wound veil and abd. Patient has a latex allergy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004170064-2017-00007 |
| MDR Report Key | 6649943 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-19 |
| Date of Report | 2017-06-09 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-06-19 |
| 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 4CM X 4CM |
| Generic Name | PRIMATRIX |
| Product Code | KGN |
| Date Received | 2017-06-19 |
| Catalog Number | 607-001-440 |
| Lot Number | 1510002 |
| 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 | 2017-06-19 |