MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-19 for PRIDE MOBILITY PRODUCTS UNKNOWN N/A manufactured by Pride Mobility Products.
[136484554]
The exact "date of event" was not provided. The "model #" and "serial #" were not provided. The user disposed of lift chair, but kept black box. Should further information become available, a follow-up report will then be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136484555]
Received letter alleging (b)(6) yr. Old user raised her lift chair and when she released controller it kept going and did not stop. She fell out and landed on her face. The local dealer in (b)(6) reported that the hand controller functioned properly. The user disposed of lift chair, but kept black box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2019-00013 |
| MDR Report Key | 8349407 |
| Report Source | CONSUMER |
| Date Received | 2019-02-19 |
| Date of Report | 2019-10-08 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-01-27 |
| Date Added to Maude | 2019-02-19 |
| 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 | 2019-02-19 |
| Returned To Mfg | 2019-10-08 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization | 2019-02-19 |