MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-09 for ARTHREX DX MATRIX 30031-02 manufactured by Dsm Biomedical.
[82150273]
A design history review was conducted. The product met all acceptance criteria; packaging and sterilization were performed in accordance with pre-determined, validated parameters. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[82150274]
It was reported approximately 2 weeks after implantation that the patient complained about "afflictions": fever (39. 6? ); shivers; wound was red with secretions; painful restriction of motion. Second arthroscopic surgery was necessary. Arthrex dx was removed; surgeon did a debridement and a lavage, and inserted a drain. A specimen was collected which did not show any microbiologic correlative germs. Three days later, surgeon did another lavage and inserted a new drain. Patient remained in the hospital for 12 days after the second surgery. The device was discarded by the facility because it was "putrid".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00004 |
| MDR Report Key | 6776998 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-04-22 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2017-02-13 |
| Date Added to Maude | 2017-08-09 |
| 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 DRIVE |
| 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 | 2017-08-09 |
| Model Number | 30031-02 |
| Lot Number | E0361 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-09 |