FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3940231
·
Received July 17, 2014
Report
- Report Number
- 2530130-2014-00056
- Event Type
- Injury
- Date Received
- July 17, 2014
- Report Date
- January 26, 2015
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- INO
- PMA / PMN Number
- K070950
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF INCIDENT HAS NOT BEEN PROVIDED AND THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Additional Manufacturer Narrative · 1
THE ALLEGED EVENT COULD NOT BE DUPLICATED.
Description of Event or Problem · 1
CONSUMER ALLEGES THE BACK DOES NOT LOCK PROPERLY AND HAS FALLEN OUT SEVERAL TIMES BACKWARDS.
Description of Event or Problem · 1
CONSUMER ALLEGES THE BACK DOES NOT LOCK PROPERLY AND HAS FALLEN OUT SEVERAL TIMES BACKWARDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418685 | PRIDE MOBILITY PRODUCTS | ELECTRIC POSITIONING CHAIR | INO | PRIDE MOBILITY PRODUCTS | GL358PWKD | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization |