MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-11 for NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522 NA:RHA450-1 RHA450-1 manufactured by Invacare Taylor Street.
[141624450]
Invacare is filing this record in an abundance of caution. The patients husband included pictures with his notification. The first picture shows what appears to be a large laceration, there is nothing in the picture to assist in accurately judging size. The second picture shows the control handle. The control handle does not appear to have any deficiencies, nor are there any allegations of malfunction. The reported issue has not been verified, and the underlying cause cannot be definitively determined. The most probable cause is the patient hit her leg on the control handle with increased force from a spasmodic jerk caused by the tone in her r. Leg. Invacare requested the return of the lift. The husband declined to return to the lift stating it was functioning fine and he needs it to transport his wife. He said that he will try and return the pump in a couple of months. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[141624451]
The end user? S husband alleges the end user obtained a laceration to her shin while she was being raised on the rha450-1 lift. He relates the end user has a lot of tone in her right leg. The end user? S right toe got caught underneath the bottom of the pump handle and her leg came up forcibly and hit the bottom edge of the control handle causing a laceration to the shin. He stated that the end user has thin skin. No medical attention was sought, the laceration was treated by the husband with sterile strips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2019-00008 |
| MDR Report Key | 8504787 |
| Report Source | CONSUMER |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2019-04-11 |
| 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. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NLA HYDRAULIC LIFT W/ADJ BASE-PLUS 9153633522 |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2019-04-11 |
| Model Number | NA:RHA450-1 |
| Catalog Number | RHA450-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-11 |