MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for BARIATRIC ROLLATOR NA:66550 66550 manufactured by Kenstone Metal Co Ltd.
[175076169]
The end user did not receive any medical treatment for the fracture. This event happened approximately 3 years ago, shortly after the end user received the rollator. She continued to use the rollator after the incident. The rollator has never been serviced. The end user stated she was communicating this incident now due to the brakes needed to be tightened. The rollator has been replaced. A return was requested; however, the dealer has not returned the rollator at this time. The owner? S manual includes the following warnings/instructions: the brakes must be in the locked position before using the seat. When using the rollator in a stationary position, the hand brakes must be locked. Verify operation of the brakes and have them adjusted if necessary. Contact your invacare dealer for brake adjustment.
Patient Sequence No: 1, Text Type: N, H10
[175076170]
The end user received the invacare 66550 bariatric rollator in (b)(6) 2016, when she was recuperating from pancreatic surgery. A couple days after receiving the rollator, she went to sit on it and one of the brakes did not hold. She fell and was taken to the emergency room for x-rays. She had a hairline fracture of her pelvis and bruising on her right hip and lower back region.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00004 |
| MDR Report Key | 9587945 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-10-10 |
| Date Facility Aware | 2020-02-18 |
| Report Date | 2020-01-14 |
| Date Reported to FDA | 2020-01-14 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2015-12-08 |
| Date Added to Maude | 2020-01-14 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARIATRIC ROLLATOR |
| Generic Name | ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2020-01-23 |
| Model Number | NA:66550 |
| Catalog Number | 66550 |
| Lot Number | KS151208 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENSTONE METAL CO LTD |
| Manufacturer Address | 222 ZHANJING EAST ROAD SUZHOU, JIANGSU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |