FDA Adverse Event
Malfunction
Summary report: N
ESSENTIAL ROLLATOR
MDR report key: 1458379
·
Received May 15, 2009
Report
- Report Number
- 1056127-2009-00006
- Event Type
- Malfunction
- Date Received
- May 15, 2009
- Date of Event
- February 8, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ESSENTIAL MEDICAL SUPPLY, INC.
- Product Code
- ITJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS OF 04/08/09, ESSENTIAL MEDICAL SUPPLY HAS NOTIFIED ITS CONSIGNEES THAT A RECALL HAS BEEN INITIATED FOR W1700B AND W1700R ESSENTIAL ROLLATORS WITH SERIAL NUMBERS RANGING FROM (B)(4)UP TO (B)(4). THE DEVICE INVOLVED IN THIS EVENT IS IN THE AFFECTED SERIAL NUMBER RANGE. THE DEVICE MALFUNCTIONED DUE TO THE PROBLEM ADDRESSED BY THE RECALL. THIS MDR WAS GENERATED DUE TO A REVIEW OF PREVIOUS COMPLAINT FILES RELATED TO THIS RECALL.
Description of Event or Problem · 1
PT SAID THAT THE WHEEL FELL OFF, CAUSING THE PT TO FALL. INSISTED THERE WAS NO INJURY BEYOND SORENESS OR BRUISING FOLLOWING THE FALL. PT WEIGHS APPROXIMATELY (B)(6), AND IS ON MEDICATION THAT MAKES HIM WEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSENTIAL ROLLATOR | WALKER, MECHANICAL | ITJ | ESSENTIAL MEDICAL SUPPLY, INC. | W1700B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |