MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-22 for NLA SEE ITEM 9201BL ALUM TRANS 19 IN BLUE W/FTRST 9153640160 NA:LTTB19FR LTTB19FR manufactured by Danyang Maxthai Medical Equipment Co Ltd.
[176281143]
The caller said she was not sure how or why the positioning strap became unfastened, she was not sure if it malfunctioned or wasn't fastened correctly. She was not aware what. Or if any maintenance has been done to the chair. She said it isn't necessary to return the chair, she just wants a replacement. The wheelchair was discontinued (b)(6) 2015, therefore a replacement was not sent. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176281144]
The patient has a 6 year old invacare transport chair, model lttb19fr. The caller said the seat belt came undone while the end user was in the chair, and she fell forward and hit her head on a table. The patient was taken to the emergency room where she received 6-8 stitches above her eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2020-00006 |
| MDR Report Key | 9617370 |
| Report Source | CONSUMER |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-29 |
| Report Date | 2020-01-22 |
| Date Reported to FDA | 2020-01-22 |
| Date Reported to Mfgr | 2020-01-22 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2020-01-22 |
| 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 | NLA SEE ITEM 9201BL ALUM TRANS 19 IN BLUE W/FTRST 9153640160 |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2020-01-22 |
| Model Number | NA:LTTB19FR |
| Catalog Number | LTTB19FR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANYANG MAXTHAI MEDICAL EQUIPMENT CO LTD |
| Manufacturer Address | DANYANG LIANHU INDUSTRIAL PARK ?DANYANG, ?JIANGSU? 212300 CH 212300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |