MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-10-06 for RITTER 104-035 manufactured by Midmark Corp..
[1774487]
Pt slid off the foot step and cut her leg on the foot step front requiring nine stitches. There is a sharp edge to the foot step front. The pt was not very mobile, required a caregiver to help her.
Patient Sequence No: 1, Text Type: D, B5
[8740657]
The exam table involved in the incident was 30 years old. An independent service tech was sent to evaluate the table. The tech reported that the edge banding on the step front was missing. We believe the missing banding contributed to this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2010-00009 |
| MDR Report Key | 1864778 |
| Report Source | 08 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-10-05 |
| Date of Event | 2010-09-10 |
| Date Mfgr Received | 2010-09-10 |
| Device Manufacturer Date | 1980-07-01 |
| Date Added to Maude | 2010-10-14 |
| 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 | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER |
| Generic Name | CHAIR, BLOOD DONOR |
| Product Code | FML |
| Date Received | 2010-10-06 |
| Model Number | 104-035 |
| 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. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-06 |