STOMAHESIVE PASTE
Received Aug 1, 2014 · Event occurred Sep 7, 2011
Report 2243969-2014-10407 · MDR key 4039807
Device
Product problems
- Human-Device Interface Problem
Patient
UNK
- Ulceration
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. TWELVE MONTHS OF COMPLAINT HISTORY DATA WAS REVIEWED FOR THIS PRODUCT ICC. BASED ON THE REVIEW, (B)(4) CASES WERE REGISTERED FOR ALLERGIC REACTION WITH ICC NUMBER (B)(4) WITHIN THE PREVIOUS 12 MONTHS. CONVATEC WILL CONTINUE TO MONITOR THESE COMPLAINTS.
Description of Event or Problem
REPORT RECEIVED INDICATED THAT THE PATIENT WAS PRESCRIBED AN OSTOMY PASTE TO USE ON A "DIABETIC-TYPE" ULCERATION IN ORDER TO ENSURE A PROPER SEAL WITH A WOUND VACUUM. AFTER A FEW HOURS, THE PATIENT REPORTED THEY BEGAN TO FEEL "STRANGE, UNEASY, ANXIOUS AND PARANOID AND STARTED TO HAVE MILD HALLUCINATIONS AND/OR DELUSIONS. THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION; HOWEVER, NO DETAILS REGARDING THE NATURE OF THE TREATMENT RENDERED WERE PROVIDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.