MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-20 for FOREARM CRUTCHES - JUNIOR 9153627267 6153 manufactured by Genteel Homecare Products.
[45633241]
Dealer states a portion of the upper cuff assembly is worn so much that it cut the end user's arm and required stitches. Dealer states he has not seen the unit but he thinks there might be a sharp edge, and he states the end user had fallen, and when he fell that is when this sharp edge cut him. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[48362588]
Product was returned for evaluation. The return fields in oracle state: walkers. Other, hold for detailed evaluation. Product received expanded evaluation. The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for having one crutch with a cuff cover that was split which exposed the steel underneath the cover. Based on the observations of the returned crutches, it was undetermined whether the exposed steel was the cause of the alleged cut. Complaint was confirmed. The underlying cause could not be determined after reviewing the documentation in this investigation. Dealer states a portion of the upper cuff assembly is worn so much that it cut the end user's arm and required stitches. Dealer states he has not seen the unit but he thinks there might be a sharp edge, and he states the end user had fallen, and when he fell that is when this sharp edge cut him. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2016-00013 |
| MDR Report Key | 5670304 |
| Date Received | 2016-05-20 |
| Date of Report | 2016-06-16 |
| Date Facility Aware | 2016-06-16 |
| Report Date | 2016-05-18 |
| Date Reported to FDA | 2016-05-18 |
| Date Reported to Mfgr | 2016-05-18 |
| Date Added to Maude | 2016-05-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOREARM CRUTCHES - JUNIOR 9153627267 |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2016-05-20 |
| Returned To Mfg | 2016-06-16 |
| Model Number | 6153 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENTEEL HOMECARE PRODUCTS |
| Manufacturer Address | LIYU INDUSTRY AREA DANZAO NANHAI FOSHAN 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-05-20 |