DETACHOL ADHESIVE REMOVER

Additional Manufacturer Narrative

THIS ADVERSE EVENT WAS REPORTED OUT OF AN ABUNDANCE OF CAUTION SINCE (B)(6) UNIVERSITY CANNOT PROVIDE DETAILS OF DEATH BECAUSE OF HIPAA REGULATIONS. AS NOTED ABOVE, (B)(6) CONFIRMED THE DEATH WAS NOT ASSOCIATED WITH DETACHOL. ALL DETAILS HAVE BEEN CAPTURED WITHIN FLIS COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

(B)(6) DIRECTOR OF RISK MANAGEMENT AT (B)(6) UNIVERSITY, CONTACTED ELOQUEST HEALTHCARE ON (B)(6) 2023, TO REPORT BLEEDING ASSOCIATED WITH DETACHOL ADHESIVE REMOVER, LOT NUMBER UNKNOWN. DETACHOL ADHESIVE REMOVER IS MARKETED BY ELOQUEST HEALTHCARE AND IS MANUFACTURED BY FERNDALE LABORATORIES, INC. (FLI). THIS INFORMATION WAS FORWARDED TO FLI QUALITY ASSURANCE DEPARTMENT ON (B)(6) 2023. MS. (B)(6) REPORTED THAT AFTER UNDERGOING AN EEG PROCEDURE AT THE PEDIATRIC ICU, A 7-MONTH-OLD PATIENT EXPERIENCED BLEEDING ALONG THE NECK AREA AFTER MEDICAL STAFF USED DETACHOL TO REMOVE THE ADHESIVE FROM THE CHILD'S HAIR/HEAD. SHE STATED THAT THE PRODUCT WAS USED AS A "SHAMPOO ALL OVER THE CHILD'S HAIR/HEAD," BUT ALSO DRIPPED DOWN THE CHILD'S NECK. IN HER WORDS, SHE WANTED TO BE "HONEST AND TRANSPARENT" THAT SHE DID NOT THINK THAT THE CHILD'S NECK WAS THOROUGHLY WASHED AFTER THE PRODUCT CAME IN CONTACT WITH HIS/HER NECK. SHE ALSO MENTIONED CHG (CHLORHEXIDINE), WAS APPLIED, BUT WASN'T SURE IF THEY (DOCTORS AND NURSES) USED THE ANTISEPTIC AFTER THE REACTION TO DETACHOL, AS IT WAS NOT REPORTED IN THE CHILD'S MEDICAL RECORDS. ACCORDING TO MS. (B)(6) (DURING THE (B)(6) 2023 PHONE CALL) THE 7-MONTH-OLD CHILD HAS SINCE DECEASED, HER PASSING WAS STATED TO NOT BE RELATED TO THE APPLICATION NOR REACTION WITH THE USE OF DETACHOL. THE FIELD SAMPLE IS NOT AVAILABLE TO RETURN. EMAIL MESSAGES WERE FORWARDED TO THE APPROPRIATE ELOQUEST HEALTHCARE TEAM MEMBERS TO ALERT OF THE APPARENT MISUSE OF THE PRODUCT ON (B)(6) 2023 AND TO FOLLOW-UP WITH (B)(6) UNIVERSITY ACCORDINGLY FOR PROPER USE OF THE DEVICE.