PURITAN
Received Jan 5, 2015 · Event occurred Oct 6, 2014
Report 1216735-2014-00003 · MDR key 4404260
Device
Generic name
Wound Measure Device
Manufacturer
Puritan Medical Products Company LlcModel number
1506 1PF DMCatalog number
1506 1PF DM
Lot number
UNK
Product problems
- Loss of or Failure to Bond
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
RN WAS MEASURING PT ABDOMINAL WOUND UPWARDS TOWARD 12 O'CLOCK USING PLASTIC FOAM TIPPED MEASURING DEVICE. WHEN REMOVED APPLICATOR, REALIZED THAT FOAM TIP WAS NO LONGER ON STICK. USED FLASHLIGHT TO LOOK UPWARD TO SEE IF COULD BE RETRIEVE ANY FOAM THAT MAY HAVE BEEN LEFT IN WOUND BUT UNABLE TO SEE ANY. PT WAS ADMITTED FOR SURGICAL REMOVAL OF SPONGE. SPONGE REMOVE FROM WOUND.
Additional Manufacturer Narrative
THIS INCIDENT IS A CLAIM FROM OVER (B)(4) WOUND DEVICES DISTRIBUTED OVER THE LAST 3 YEARS. OUR INVESTIGATION COULD NOT REPRODUCE A DEFECT THAT WOULD ACCOUNT FOR THIS CLAIM.