TENDERFOOT 50PK DEVICES
Received Mar 31, 2011 · Event occurred Mar 13, 2011
Report 2250033-2011-00007 · MDR key 2068117
Device
Product problems
- Retraction Problem
- Improper or Incorrect Procedure or Method
- Protective Measures Problem
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
(B)(4). METHOD: NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. NO OTHER COMPLAINTS WERE RECEIVED FOR THIS LOT. A SEARCH OF COMPLAINTS FOR THE PAST 2 YEARS INDICATES NO OTHER CASES OF FAILURE TO RETRACT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTS USER INJURY USING TENDERFOOT 50PK DEVICE. CUSTOMER REPORTED THAT A NURSE WAS USING THE DEVICE TO INCISE A PT. SHE PUT THE DEVICE DOWN ON THE COUNTER EXPECTING THE BLADE TO HAVE RETRACTED. CLEANING UP AFTERWARDS, SHE PICKED UP THE DEVICE AND CUT HER RIGHT THUMB. THE CUT WAS TREATED USING STANDARD NEEDLESTICK PROTOCOL FOR THE SITE. THE CUT WAS WASHED OUT AND WIPED WITH ALCOHOL. NO ADVERSE EVENT (S) REPORTED.