FDA Adverse Event
Summary report: N
BESTCARE
MDR report key: 4802392
·
Received February 25, 2015
Report
- Report Number
- MW5042853
- Date Received
- February 25, 2015
- Date of Event
- November 26, 2014
- Report Date
- February 24, 2015
- Manufacturer
- BESTCARE LLC
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BESTCARE LIFT SLING FAILED AT TWO (2) POINTS DURING USE. THE FOOT END SLING CONNECTORS (LOOP STRAP) SNAPPED FROM THE SLING LIFT SHEET WHILE RESIDENT WAS BEING TRANSFERRED TO A WHEELCHAIR. INITIAL REPORTER: (B)(6). BECAME AWARE OF EVENT: (B)(6)2015. APPROXIMATE AGE OF DEVICE: UNKNOWN. REMEDIAL ACTION: REFUNDED. PRODUCT IS MANUFACTURED BY BESTCARE LLC. DISTRIBUTED BY (B)(4). PLEASE SEE FDA REPORT NUMBER# MW5040199.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134557 | BESTCARE | BESTCARE # 78253 | FSA | BESTCARE LLC | 78253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |