MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-23 for PRIDE MOBILITY PRODUCTS LC358L N/A manufactured by Pride Mobility Products.
[142753491]
The device has not yet been made available for evaluation. Should further information or the device become available for evaluation, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10
[142753492]
Alleges consumer's partner was sleeping in the chair when all of a sudden one side of the chair came loose from the bracket which caused the back to give away. The consumer's partner fell over the side of the chair and had to call the fire department to help her up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2019-00048 |
| MDR Report Key | 8539608 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-23 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-04-20 |
| Date Mfgr Received | 2019-04-22 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-23 |
| 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 | MISS KELLY LIVINGSTON |
| Manufacturer Street | 401 YORK AVE |
| Manufacturer City | DURYEA PA 18642 |
| Manufacturer Country | US |
| Manufacturer Postal | 18642 |
| Manufacturer Phone | 5706024056 |
| Manufacturer G1 | N/A |
| Manufacturer Street | N/A N/A |
| Manufacturer City | N/A |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIDE MOBILITY PRODUCTS |
| Generic Name | ELECTRIC POSITIONING CHAIR |
| Product Code | INO |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-05-15 |
| Model Number | LC358L |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIDE MOBILITY PRODUCTS |
| Manufacturer Address | 401 YORK AVE DURYEA PA 18642 US 18642 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |