MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-21 for DYNA MED manufactured by .
[1638853]
Design of product changed a few years ago. Product is engineered poorly. Order for 7 placed, on arrival 4 were out of box defective. Company replaced 4 and upon delivery 3 were out of box failures. Locking mechanism failures and kickstand and mechanical traction. Red clips fail constantly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016435 |
| MDR Report Key | 1732882 |
| Date Received | 2010-06-21 |
| Date of Report | 2010-06-21 |
| Date of Event | 2010-06-01 |
| Date Added to Maude | 2010-06-24 |
| 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 |
| 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 | DYNA MED |
| Generic Name | TRACTION SPLINT |
| Product Code | ILZ |
| Date Received | 2010-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-21 |