FDA Adverse Event
Injury
Summary report: N
INVACARE SHOWER / BATH SUPPORT PRODUCTS
MDR report key: 1003019
·
Received February 25, 2008
Report
- Report Number
- 1525712-2008-00013
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- January 23, 2008
- Report Date
- February 20, 2008
- Manufacturer
- INVACARE CORP. - MANUFACTURING FACILITY
- Product Code
- INM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
PATIENT REPORTEDLY CUT THEIR FOOT DURING A TRANSFER INTO THE CHAIR. MANUFACTURER CONTACTED USER AND WAS ADVISED AFTER THE USERS AID HAD TRANSFERRED HER INTO THE CHAIR. USER NOTICED THEIR RIGHT TOE HAD BEEN CUT DUE TO IMPACTING THE CHAIR WHILE BEING TRANSFERRED. NO HISTORY TO SUGGEST A PRODUCT PROBLEM. MDR FILED BASED ON INJURY. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS.
Description of Event or Problem · 1
THE CONSUMER ALLEGEDLY CUT THEIR FOOT ON THE BOLTS FOR THE HEEL LOOPS, REQUIRING 5 STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE SHOWER / BATH SUPPORT PRODUCTS | 890.3100 | INM | INVACARE CORP. - MANUFACTURING FACILITY | 6895 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |