MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-01 for PRIDE MOBILITY PRODUCTS HA2043-21 N/A manufactured by Pride Mobility Products.
[126553438]
The "date of event" has not been provided. The device has not been made available for evaluation at this time. Should the device or more information become available, a follow-up report will then be issued.
Patient Sequence No: 1, Text Type: N, H10
[126553439]
Alleges right side of the hub assembly has broken at the weld.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2018-00158 |
| MDR Report Key | 8028530 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-01 |
| Date of Report | 2019-01-31 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-11-01 |
| 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 N/A |
| Manufacturer City | DURYEA PA 18642 |
| Manufacturer Country | US |
| Manufacturer Postal | 18642 |
| Manufacturer Phone | 5706555574 |
| Manufacturer G1 | N/A |
| Manufacturer Street | N/A N/A |
| Manufacturer City | N/A |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIDE MOBILITY PRODUCTS |
| Generic Name | WHEELCHAIR COMPONENT |
| Product Code | KNN |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-29 |
| Model Number | HA2043-21 |
| 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 N/A DURYEA PA 18642 US 18642 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-01 |