MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-14 for TILT IN SPACE NA:SOLARA3G SOLARA3G manufactured by Invacare Taylor Street.
[175075605]
The caregiver related she broke the part while attempting to place the chair into the back of the van. No malfunction of the device was alleged. The caregiver was referred to a service center for a new part. The event has not been determined to be the result of a device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[175075606]
The caregiver was putting the solara3g wheelchair in the back of a van, and the left trigger to recline the chair broke, and cut her left pointer finger. The caller advised she went to a walk in clinic and they had to give her two stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2020-00005 |
| MDR Report Key | 9587995 |
| Report Source | CONSUMER |
| Date Received | 2020-01-14 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2011-01-01 |
| 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 Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| 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 | TILT IN SPACE |
| Generic Name | WHEELCHAIR, MANUAL |
| Product Code | IOR |
| Date Received | 2020-01-14 |
| Model Number | NA:SOLARA3G |
| Catalog Number | SOLARA3G |
| Operator | LAY USER/PATIENT |
| 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 | 2020-01-14 |