MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-06-22 for ARTHREX DX MATRIX 30031-02 manufactured by Dsm Biomedical.
[78176361]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[78176362]
It was reported that a (b)(6) year old female with a normal bmi received an arthrex dx matrix device arthroscopically on the (b)(6) 2017. On the (b)(6) 2017 the patient had an inflamed reaction with an effusion. Bacterial infection was excluded as the culture findings were negative. The implant was removed in stages as the implant was unstable during removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00002 |
| MDR Report Key | 6660370 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2017-06-22 |
| 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 | MRS. ALICE COUSENS |
| Manufacturer Street | 735 PENNSYLVANIA |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132165 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX DX MATRIX |
| Generic Name | MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXH |
| Date Received | 2017-06-22 |
| Model Number | 30031-02 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | 735 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-22 |