Brand Name | PRIDE MOBILITY PRODUCTS |
Type of Device | CHAIR, POSITIONING, ELECTRIC |
Manufacturer (Section D) |
PRIDE MOBILITY PRODUCTS |
401 york ave |
duryea PA 18642 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
kelly
livingston
|
401 york ave |
duryea, PA 18642
|
5706024056
|
|
MDR Report Key | 16148076 |
MDR Text Key | 307193873 |
Report Number | 2530130-2023-00006 |
Device Sequence Number | 1 |
Product Code |
INO
|
UDI-Device Identifier | 00606509400930 |
UDI-Public | 00606509400930 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091578 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/16/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Model Number | PLR975M |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Manufacturer Received | 01/06/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/23/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Male |
|
|