MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-14 for MIDMARK 622-008 manufactured by Midmark Corp..
[20217714]
A medical assistant was lowering the back down on the table. The employee had their arm behind the back section to assist in doing this when the back collapsed onto her arm. She jerked her arm to try to bring it out from under the back and injured her shoulder.
Patient Sequence No: 1, Text Type: D, B5
[20575811]
We were unable to evaluate the broken component. The component was replaced and discarded prior to midmark becoming aware of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00009 |
| MDR Report Key | 2068663 |
| Report Source | 06 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-03-22 |
| Date Mfgr Received | 2011-03-22 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2011-05-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-04-14 |
| Model Number | 622-008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |