MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-11 for CANE, CRUTCH AND WALKER TIPS AND PADS G6271 manufactured by Unknown.
[4346791]
It was reported that glide tips are hard to roll and are sticking, making it difficult to maneuver the unknown walker. The end user reportedly fell forward while using the walker, however, no injury was reported as a result.
Patient Sequence No: 1, Text Type: D, B5
[11697652]
Submission of this mdr, under this part does not constitute an admission that the device and/or any employee, caused or contributed to the reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2014-01104 |
| MDR Report Key | 3673420 |
| Report Source | 08 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2014-03-11 |
| Date Added to Maude | 2014-05-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREGORY STEVENS |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer City | OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANE, CRUTCH AND WALKER TIPS AND PADS |
| Generic Name | 890.3790 |
| Product Code | INP |
| Date Received | 2014-03-11 |
| Model Number | G6271 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-11 |