SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP

Description of Event or Problem

CLINICIAN BROKE OUT IN HIVES ON HER FACE (ESPECIALLY AROUND HER EYES) THE REACTION THEN MOVED DOWN THE TRUNK OF THE BODY. TOOK ORAL BENADRYL. THE REACTION THEN PROGRESSED TO A HOARSE VOICE AND LIPS STARTED SWELLING. WENT TO THE ER AT THAT POINT. PULSE AND BLOOD PRESSURE WERE BOTH ELEVATED AT THE ER. WAS GIVEN IV SOLUMEDROL, IV PEPCID, FLUIDS AND IV BENADRYL. WAS SENT HOME FROM THE ER WITH PRESCRIPTIONS FOR PREDNISONE, PEPCID AND AN EPI PEN. 2024-01-18 THE BOTTLE OF SPRAY SOLUTION FELL OVER, BROKE AND LEAKED ALL OVER THE TOP OF A CART. CLINICIAN CLEANED UP A LARGE VOLUME OF THE SPILL WITH PAPER TOWELS (WAS NOT WEARING GLOVES) AND WASHED HER HANDS. SHE HAD NOT EVER USED OR TOUCHED THIS PRODUCT PRIOR TO CLEANING UP THE SPILL. (B)(6) 2024 WITHIN 1.5 - 2 HOURS OF CLEANING UP THE SPILL, SHE BROKE OUT IN HIVES ON HER FACE (ESPECIALLY AROUND HER EYES) THE REACTION THEN MOVED DOWN THE TRUNK THE BODY. (B)(6) 2024 TOOK ORAL BENADRYL. THE REACTION THEN PROGRESSED TO A HOARSE VOICE AND LIPS STARTED SWELLING. WENT TO THE ER AT THAT POINT. PULSE AND BLOOD PRESSURE WERE BOTH ELEVATED AT THE ER. WAS GIVEN IV SOLUMEDROL, IV PEPCID, FLUIDS AND IV BENADRYL. WAS SENT HOME FROM THE ER WITH PRESCRIPTIONS FOR PREDNISONE, PEPCID AND AN EPI PEN. (B)(6) 2024- STILL HAD SOME SWELLING ON EYELIDS. (B)(6) 2024 CONDITION HAD COMPLETELY RESOLVED. (B)(6) 2024 - IN THE PAST COUPLE OF WEEKS, CLINICIAN HAD MULTIPLE EPISODES OF HIVES. SAW AN ALLERGIST (B)(6) 2024 AND HE WANTS HER TO WAIT TWO WEEKS AND THEN DO A PATCH TEST WITH THE SPRAY.

Additional Manufacturer Narrative

PARKER HAS REVIEWED THE DETAILS OF THE COMPLAINT WITH THE INITIAL REPORTER TO VERIFY THAT WE HAVE ALL INFORMATION AVAILABLE. COMPLAINT FILES WERE REVIEWED AND THERE HAVE BEEN NO RELATED COMPLAINTS. PARKER LABS IS AWAITING SAMPLE RETURN FOR INVESTIGATION. SINCE NO LOT# IS AVAILABLE PARKER IS NOT ABLE TO INVESTIGATE RETAINS/BATCH RECORDS. PLEASE NOTE THAT THE PRODUCT CODE IS GYB. HOWEVER, IT WAS NOT AN OPTION ON THE LIST SO JOT WAS SELECTED.

Additional Manufacturer Narrative

CUSTOMER WILL NOT BE SHIPPING THE PRODUCT BACK TO PARKER LABS.

Description of Event or Problem

2024-03-06 - CLINICIAN HAD A PATCH TEST WITH THE ELECTRODE SPRAY AND SHE DID NOT REACT TO IT. HER DOCTORS HAVE RULED OUT THE ELECTRODE SPRAY CAUSING AN ALLERGIC REACTION.