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 |