MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-02-29 for WHEELCHAIR ACCESSORY R121 manufactured by New Prokin.
[21753193]
The toileting sling was attached to a ceiling lift. While attempting to lift the patient from bed, the patient allegedly fell from sling. Serious injury alleged.
Patient Sequence No: 1, Text Type: D, B5
[21859853]
No rma has been initiated for this issue at the time of this report. Model r121 toileting sling, serial number/date code is unknown. The owner's manual part number 1023891 was issued with this device. The owner's manual is also found on-line at invacare. Com. It is unknown if the consumer has fully read and understands the owner's manual. Documentation provides warnings, cautions, and instructions for safely using the device. If the consumer does not understand the written warnings, cautions or instructions then they should contact invacare. The consumers age, height and weight are unknown. The consumers medical condition, stability and medication regimen are unknown. The consumers technique while using the device is unknown. The maintenance history of the device is unknown. The incident report stated that the toileting sling was attached to a ceiling lift. Invacare does not sell a ceiling lift in the united states. The user manual for invacare's toileting sling states on pg. 7 that the toileting sling is designed to be used only with specific invacare lifts, stating that the color coded sling loops on the sling provide an easy way to position the patient. A ceiling lift is not indicated in the user manual. It is unknown if the toileting sling is an actual invacare product until the sling is returned to invacare. The patient allegedly fell from the sling when being lifted from the bed. The patient refused to be taken to the hospital by the ambulance at the time of the incident, but allegedly went to the hospital the following day. The patient's daughter alleges that the patient suffered a stroke and bleeding on the brain. It is unknown if the alleged serious injury is a result of the alleged sling incident. The dealer refused to provide any patient information due to hipaa.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1531186-2012-00015 |
| MDR Report Key | 2471803 |
| Report Source | * |
| Date Received | 2012-02-29 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-02-07 |
| Date Facility Aware | 2012-02-14 |
| Report Date | 2012-02-28 |
| Date Reported to FDA | 2012-02-28 |
| Date Reported to Mfgr | 2012-02-28 |
| Date Added to Maude | 2012-02-29 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR ACCESSORY |
| Generic Name | 890.3910 |
| Product Code | KNO |
| Date Received | 2012-02-29 |
| Model Number | R121 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW PROKIN |
| Manufacturer Address | ZHONGSHAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-29 |