FDA Adverse Event
Injury
Summary report: N
COMPASS HEALTH BRANDS
MDR report key: 20074481
·
Received August 27, 2024
Report
- Report Number
- 3012316249-2024-00014
- Event Type
- Injury
- Date Received
- August 27, 2024
- Report Date
- August 27, 2024
- Manufacturer
- JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
- Product Code
- INM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
AMAZON LISTING NOTIFICATION: THE LISTINGS BELOW ARE AT RISK OF DEACTIVATION DUE TO POTENTIAL SAFETY CONCERNS FOR A PRODUCT SOLD BY YOU. YOU CAN FIND DETAILS OF THE AT-RISK LISTINGS BELOW. AFFECTED PRODUCTS: B008XI2UBI - CAREX TRANSPORT WHEELCHAIR WITH 19 INCH SEAT - FOLDING TRANSPORT CHAIR WITH FOOTRESTS - FOLDABLE WHEELCHAIR AND LIGHTWEIGHT FOLDING WHEELCHAIR FOR STORAGE AND TRAVEL. ASIN VARIATIONS: B008XI2UBI, B0CJCVPZ1H. ROOT CAUSE OF THE INCIDENT: 2024/8 - PRODUCT MALFUNCTIONS THAT CAUSE DISLOCATION OF BODY PART REQUIRING SETTING/SLING/SPLINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1218902 | COMPASS HEALTH BRANDS | TRANSPORT CHAIR | INM | JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. | FGA33677 0000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |