MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-17 for SPAN AMERICA 37052 manufactured by Span America Medical Systems, Inc..
[64976754]
Mat was not defective, wet underneath.
Patient Sequence No: 1, Text Type: N, H10
[64976755]
Cna (care giver) answered the call light and put the patient back in bed. As she walked away the bedside fall mat slipped and she fell to the floor bruising the left side of her leg. No immediate first aid or medical attention was given; however, she did later go to a doctor for x-rays which were negative. She was prescribed ibuprofen and baclofen. The incident report from both the employee and her supervisor state the reason for the slip was the bedside safety mat was wet underneath causing it to slide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1041130-2017-00001 |
| MDR Report Key | 6257771 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2017-01-17 |
| 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 | MR. 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 | SPAN AMERICA |
| Generic Name | BEDSIDE FALL MATT |
| Product Code | IKX |
| Date Received | 2017-01-17 |
| 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 | 2017-01-17 |