FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_INSTRUMENTS_PRODUCT
MDR report key: 3170726
·
Received June 14, 2013
Report
- Report Number
- 0001811755-2013-01387
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KCY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE TOURNIQUETS WERE NOT STRYKER TOURNIQUETS. THE 0001811755-2013-01386 REFERS TO THE SECOND TOURNIQUET.
Description of Event or Problem · 1
IT WAS REPORTED THAT SKIN BLISTERS WERE DISCOVERED FOLLOWING THE REMOVAL OF A TOURNIQUET CUFF. ATTEMPTS ARE BEING MADE TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT SKIN BLISTERS WERE DISCOVERED FOLLOWING THE REMOVAL OF A TOURNIQUET CUFF. ATTEMPTS ARE BEING MADE TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271045 | UNKNOWN_INSTRUMENTS_PRODUCT | PNEUMATIC, TOURNIQUET | KCY | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5920011000SMARTPUMP DUAL CHANNEL |