CUSTOM PAK
Received Oct 10, 2008 · Event occurred Sep 8, 2008
Report 1644019-2008-00030 · MDR key 1196365
Device
Generic name
Convenience Kit
Manufacturer
Alcon-houstonModel number
CUSTOM PAKCatalog number
CUSTOM PAK
Lot number
814471H
Product problems
- Sticking
Patient
Not reported
- Skin Tears
Narrative
Description of Event or Problem
THE NURSE REPORTED THAT THE DRAPE THEY NORMALLY GET WAS TEMPORARILY CHANGED IN THEIR PACK, AND WHEN REMOVING THE DRAPE AT THE END OF THE PROCEDURE TODAY, SOME OF THE PT'S FACIAL SKIN WAS ADHERED TO THE STICKY PART OF THE DRAPE AND RIPPED A LARGE AMOUNT OF THE PT'S FACIAL SKIN. SHE IS GOING TO REQUIRE ADDITIONAL TREATMENT.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 10/10/2008.