MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-11-21 for MIDMARK 204-002 manufactured by Midmark Corp..
[20008328]
Seat portion of the table fell onto the hand of a member of the nursing staff who was cleaning the table causing injury. The injury was described as severe and permanent and ultimately resulted in amputation of a digit.
Patient Sequence No: 1, Text Type: D, B5
[20339387]
Table was not returned at this time. Follow-up report will occur when evaluation of the table is complete. Based on the events described, preliminary investigation would indicate user error since this is a manual exam table with no automated parts. The report did not indicate a load or other person present during the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2012-00030 |
| MDR Report Key | 2848064 |
| Report Source | 06,07 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-11-20 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-10-23 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2012-11-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG RAMMEL |
| 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 | EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2012-11-21 |
| Model Number | 204-002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-11-21 |