MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for QUICKIE 5R EIR10 manufactured by Sunrise Medical (us) Llc.
[174696286]
Sunrise medical customer service recommended to the end user that she contact the dealer to make adjustments to the footplates. Regulatory contacted dealer (b)(6) on 1/7/20 to follow up on this issue. Per (b)(6) at (b)(6) home care, the issue has been resolved. It was a matter of simply making adjustments to the footplate in order to reposition it and bring it forward. There was no allegation of malfunction or defect made against the wheelchair. It was mentioned to (b)(6) that the end user claimed her hips were dislocated because of the position of the footplates, however he did not confirm that the end user's claim actually occurred. Although the claim of injury could not be confirmed, sunrise medical, out of an abundance of caution has decided to file this mdr. The end user (b)(6) did not provide a last name or address. The dealer (b)(6) contact information will be used for this report. Since there was no malfunction or defect with the wheelchair and the issue has been resolved by the dealer, an evaluation and further investigation will not be performed by sunrise medical.
Patient Sequence No: 1, Text Type: N, H10
[174696287]
End user contacted sunrise medical and stated that her feet are pushed a lot further back under the seat of her replacement chair than they were in her original chair. She states that with her feet being pushed/positioned back and it is dislocating her hips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937137-2020-00003 |
| MDR Report Key | 9566523 |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-01-08 |
| 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. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Manufacturer G1 | SUNRISE MEDICAL (US) LLC |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKIE 5R |
| Generic Name | MANUAL WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2020-01-08 |
| Model Number | EIR10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL (US) LLC |
| Manufacturer Address | 2842 BUSINESS PARK AVE. FRESNO CA 93727 US 93727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-08 |