A MALE PATIENT COMPLAINED OF A BURNING SENSATION WHEN THE INCONTINENCE CLEANSER WAS SPRAYED TO BUTTOCK PERINEUM AREA. REPORTER STATES THE STAFF MEMBER DID NOT SPRAY IT TOO CLOSE TO THE PATIENT STAGE II PRESSURE ULCER. SHE REPORTS PATIENT DID HAVE SOME WEEPY AREAS ON SKIN RELATED TO INCONTINENCE. THE PATIENT WAS TURNED ON HIS SIDE AND FACING AWAY FROM THE STAFF MEMBER SPRAYING THE CLEANSER AND ALSO STATES THE PATIENT COUGHED DUE TO THE SPRAY. PATIENT EXPERIENCED A BURNING SENSATION TO WEEPY SKIN AND COUGH SUBSIDED AND NO TREATMENT NEEDED. REPORTER DENIED GETTING ANY ONTO FACE AND NO EYE BURNING IRRITATION.
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Patient 1
THIS IS DEEMED A SERIOUS INJURY BECAUSE MEDICAL INTERVENTION/TREATMENT MAY BE NEEDED IF THIS ISSUE WERE TO RECUR. THE USE OF THE ALOE VESTA PERINEAL/SKIN CLEANSER IS DEEMED POSSIBLY RELATED TO THE EVENT. ACCORDING TO THE REPORTER, "NO MEDICAL TREATMENT WAS REQUIRED OR GIVEN" AND THEY DID NOT KNOW A TIME FRAME OF WHEN THE EVENT OCCURRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. (B)(4). NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.
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Patient 1
ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 15, 2015. THIRD PARTY MANUFACTURER PERFORMED A BATCH RECORD REVIEW OF LOT# G3D108 WHICH SHOWED THAT ALL PROCESSES WERE FOLLOWED DURING THE PRODUCTION OF THE BATCH AS WELL AS PACKAGING. ALL BULK AND FINISHED GOODS MET SPECIFICATIONS. TESTING OF THE RETAIN SAMPLES SHOWED THAT THE PRODUCT IS ACCEPTABLE. IT WAS CONCLUDED THAT THE COMPLAINT ISSUE WAS NOT DUE TO THE PRODUCT OR PACKAGING. AFTER A THOROUGH BATCH RECORD REVIEW, NO DISCREPANCIES OR NON-CONFORMANCES WERE DISCOVERED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.