MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for INVACARE ROLLITE ROLLATOR 65100 manufactured by Genteel Homecare Products Co., Ltd.
[175106839]
The end user reported that her husband weighs (b)(6), which is close to the weight limit of 300 pounds for the 65100 rollator. The 65100 rollator was returned to invacare for evaluation, which was completed on 02/12/2019. It was confirmed that the rollator's left front caster had sheared off at its stem. Remnants of the sheared caster stem were present on top of the caster assembly, as well as in the offset caster housing of the leg extension. Abrasions were visible on the leading side of the offset caster housing, an indication that it experienced collisions during use. The force of those collisions presumably weakened the caster stem until it finally sheared. The 65100 rollator was manufactured in june 2007, making it approximately 11. 5 years old at the time of the event. The tires/wheels and leg extensions have an expected wear period of 1 year, and the entire device has an expected life of 5 years. Therefore, the failed components and the rollator were well past their life expectancy at the time of the alleged incident. The 65100 rollator has been discontinued, so it was replaced with a different model.
Patient Sequence No: 1, Text Type: N, H10
[175106840]
The end user reported that her husband was sitting on her 65100 rollator while barbecuing, he turned in the seat to reach for a spatula, and one of the rollator wheels sheared off. She stated that her husband fell onto the deck and hit his head, and they called an ambulance which transported him to the emergency room. She advised that due to the blood thinner medication he takes, a cat scan was performed, and he received 1 or 2 glue stitches on his head. She stated that after the testing and stitches were completed, they released him and he is now back home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00002 |
| MDR Report Key | 9586581 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-01-11 |
| Date Facility Aware | 2019-01-11 |
| Report Date | 2020-01-14 |
| Date Reported to FDA | 2020-01-14 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2007-06-18 |
| 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 | INVACARE ROLLITE ROLLATOR |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2019-01-30 |
| Model Number | 65100 |
| Lot Number | GT070618 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENTEEL HOMECARE PRODUCTS CO., LTD |
| Manufacturer Address | LIYU INDUSTRY AREA, DANZAO NANHAI, GUANGDONG 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |