MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-03-13 for RISK MANAGER 37052 manufactured by Span America Medical Systems, Inc..
[5467771]
An employee was walking into a patients room and stepped one foot onto the risk manager (a bedside safety mat). As she stepped on the mat, it slipped, causing her legs to split apart. The slip of the mat caused a groin injury to the employee and she is now on light duty.
Patient Sequence No: 1, Text Type: D, B5
[13002924]
The risk manager is a fall pad designed to reduce the likelihood of a serious injury in the event of a fall at patient bad side. This device was not returned since there was not an obvious problem with the product. This product can become slick depending on the floor surface, floor cleaner and application (mat placed on wet surface), etc. We do sell "grip strips" which are available for anyone that finds a need which is included in our product insert. The facility was not using the grip strips so we have sent 5 sets for their evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1041130-2015-00001 |
| MDR Report Key | 4599678 |
| Report Source | 01,06 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-02-22 |
| Date Mfgr Received | 2015-03-02 |
| Date Added to Maude | 2015-03-13 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM DARBY |
| Manufacturer Street | 70 COMMERCE CENTER |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal | 29615 |
| Manufacturer Phone | 8646786936 |
| 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 | 3 |
| Brand Name | RISK MANAGER |
| Generic Name | BEDSIDE SAFETY MAT - FALL MAT |
| Product Code | FMP |
| Date Received | 2015-03-13 |
| Model Number | 37052 |
| Catalog Number | 37052 |
| Operator | DEVICE UNATTENDED |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-03-13 |