MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for RISK MANAGER 9611836 manufactured by Span America Medical Systems, Inc..
[115350667]
The risk manager has optional grip strips for use on certain floor surfaces to help prevent movement of the mats. The mat was not used with the grip strips.
Patient Sequence No: 1, Text Type: N, H10
[115350668]
Staff member stepped on the risk manager, the mat slipped from underneath her, she fell and landed on both wrists. She sustained bilateral wrist fracture, fracture on each wrist with casts on both wrists. She went to the er, received treatment including casts and is being followed up by the fracture clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1041130-2018-00002 |
| MDR Report Key | 7728734 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-07-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM DARBY |
| Manufacturer Street | 70 COMMERCE CENTER |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal | 29615 |
| Manufacturer Phone | 8002888877 |
| Manufacturer G1 | SPAN AMERICA MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 70 COMMERCE CENTER |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RISK MANAGER |
| Generic Name | BEDSIDE FALL MAT |
| Product Code | IKX |
| Date Received | 2018-07-27 |
| Model Number | 9611836 |
| Catalog Number | 9611836 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPAN AMERICA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 70 COMMERCE CENTER GREENVILLE SC 29615 US 29615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-07-27 |