FDA Adverse Event
Death
Summary report: N
PRIDE
MDR report key: 1824582
·
Received August 31, 2010
Report
- Report Number
- 2530130-2010-00048
- Event Type
- Death
- Date Received
- August 31, 2010
- Date of Event
- August 7, 2008
- Report Date
- August 27, 2010
- Manufacturer
- PRIDE MOBILITY PRODUCTS CORPORATION
- Product Code
- INN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN THE (B)(6) AND WAS DOCUMENTED PER THE MEDICAL DEVICES DIRECTIVES (VIGILANCE SYSTEM) MDD 93/42EEC, ARTICLE; INCIDENT REPORT #(B)(4) IS ON FILE. REPORTING THE EVENT TO THE FDA PER PART 803 OF THE CFR REQUIREMENTS.
Description of Event or Problem · 1
IT IS ALLEGED THAT THE USER PASSED AWAY DUE TO THE ENTRAPMENT OF THEIR OXYGEN SUPPLY LINE IN THE LIFT CHAIR FOOT MECHANISM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIDE | LIFT CHAIR | INN | PRIDE MOBILITY PRODUCTS CORPORATION | C15 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |