FDA Adverse Event
Injury
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3831800
·
Received May 27, 2014
Report
- Report Number
- 2530130-2014-00040
- Event Type
- Injury
- Date Received
- May 27, 2014
- Date of Event
- May 2, 2014
- Report Date
- June 23, 2014
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- PMA / PMN Number
- K042612
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 PROVIDER EVALUATED THE DEVICE. THE PROVIDER COULD NOT REPLICATE THE ISSUE. PROVIDER EVALUATED.
Description of Event or Problem · 1
CUSTOMER ALLEGES UNIT MOVES ON IT OWN RESULTING IN HIM RUNNING INTO A WALL SUSTAINING INJURY.
Description of Event or Problem · 1
CUSTOMER ALLEGES UNIT MOVES ON IT OWN RESULTING IN HIM RUNNING INTO A WALL SUSTAINING INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311617 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |