FDA Adverse Event
Injury
Summary report: N
TOURNI-COT - UNIVERSAL
MDR report key: 10795761
·
Received November 5, 2020
Report
- Report Number
- 1832653-2020-00001
- Event Type
- Injury
- Date Received
- November 5, 2020
- Date of Event
- July 1, 2020
- Report Date
- October 2, 2020
- Manufacturer
- MAR-MED INC.
- Product Code
- GAX
- UDI-DI
- 00855364004085
- PMA / PMN Number
- K853472
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
WE RECEIVED A REPORT FROM THE USER INDICATING THE PROBLEMS THEY EXPERIENCED. THEY REPORTED THERE WAS A DEVICE FAILURE AND ASSOCIATED USER ERROR. WE ARE CURRENTLY IN THE PROCESS OF REVIEWING OUR INTERNAL SYSTEMS TO SEE HOW TO ADDRESS THIS EVENT.
Description of Event or Problem · 1
FINGER TOURNIQUET WAS LEFT INSITU FOLLOWING LOCAL ANAESTHETIC PROCEDURE. IT IS UNKNOWN WHETHER IT WAS PART OR THE WHOLE DEVICE. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): THE (B)(6) YEAR OLD PATIENT'S FINGER HAD DRY GANGRENE WHICH HAD TO BE AMPUTATED. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) DEVICE REMOVED FROM USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1255083 | TOURNI-COT - UNIVERSAL | TOURNI-COT - UNIVERSAL | GAX | MAR-MED INC. | TCU | 121909-A | 00855364004085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Disability |