MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-03 for TRACTION SCALE ATTACHMENT AR-1604 manufactured by Arthrex Inc..
[2872873]
Purchased a traction scale attachment from arthrex inc. Product number (b)(4). Product deemed as a medical device. Under closer inspection of device, found another manufacturer and product number as (b)(4). A web search of this company and model number revealed that product is sold as instrument scales for fisherman and hunters. Cleaning and sterilization of medical device was generic, and when i called the company customer service line, and asked for cleaning and sterilization instructions specific to this device, was told that none was available. Very concerned that company is passing off a non-medical device was medical and surgical grade. This item is used in the sterile field, in shoulder traction surgery, and i'm afraid someone will be injured, or the sterile field contaminated by ineffectual cleaning, and sterilization of a non-medical device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026080 |
| MDR Report Key | 2651009 |
| Date Received | 2012-07-03 |
| Date of Report | 2012-07-03 |
| Date Added to Maude | 2012-07-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACTION SCALE ATTACHMENT |
| Generic Name | TRACTION SCALE |
| Product Code | FRW |
| Date Received | 2012-07-03 |
| Model Number | AR-1604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX INC. |
| Manufacturer Address | NAPLES FL 34108194 US 34108 1945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-03 |