FDA Adverse Event
Injury
Summary report: N
RECLINER
MDR report key: 302153
·
Received October 23, 2000
Report
- Report Number
- 1525712-2000-00082
- Event Type
- Injury
- Date Received
- October 23, 2000
- Report Date
- October 2, 2000
- Manufacturer
- INVACARE CORPORATION
- Product Code
- INO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MFR RECEIVED A REPORT ALLEGING THAT A PT HAD BEEN INJURED WHILE USING A RECLINER, WHEN THEIR LEG CAME INTO CONTACT WITH A PIECE OF PLASTIC ON THE CHAIR. AS A RESULT THE PT RECEIVED A CUT TO THEIR LEG THAT REQUIRED SUTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECLINER | MEDICAL CHAIR | INO | INVACARE CORPORATION | RECLINER | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |