D
Patient 1
CHOKED [CHOKING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKED IN A (B)(6) MALE PT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (POLIGRIP COMFORT STRIPS) STRIP FOR AN UNK INDICATION. THE PT'S PAST MEDICAL HISTORY INCLUDED STROKE. CONCOMITANT PRODUCTS INCLUDED MEDICATION UNKNOWN. IN 2014, THE PT STARTED POLIGRIP COMFORT STRIPS. IN 2014, AN UNK TIME AFTER STARTING POLIGRIP COMFORT STRIPS, THE PT EXPERIENCED CHOKED (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). IN 2014, THE OUTCOME OF THE CHOKED WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE CHOKED TO BE RELATED TO POLIGRIP COMFORT STRIPS. THE PT'S WIFE REPORTED THAT HER HUSBAND WAS IN A SPECIAL CARE FACILITY AS HE PREVIOUSLY HAD A STROKE. SHE STATED THAT SHE PURCHASED THE POLIGRIP COMFORT STRIPS FOR THE FIRST TIME ABOUT A MONTH AGO (APPROXIMATELY (B)(6) 2014), AND HER HUSBAND CHOKED ON IT WHEN IT WAS IN HIS MOUTH. SHE REPORTED THAT THE PRODUCT AMOUNT TAKEN WAS "AS DIRECTED". SHE REPORTED THAT USE OF THE PRODUCT WAS DISCONTINUED, AND THE REACTION RESOLVED. SHE REPORTED THAT THE PRODUCT WAS OT REINTRODUCED. FOLLOW-UP WAS RECEIVED ON 10/28/2014. THE REPORTER STATED THAT THE PRODUCT WAS PURCHASED IN (B)(6) 2014, AND ONE STRIP WAS USED. THE REPORTER STATED THAT THE PT WAS ABLE TO COUGH THE STRIP UP AND THE CONDITION HAD SUBSIDED SINCE THE INITIAL REPORT. THE REPORTER STATED THAT THE PT SWITCHED FROM STRIPS TO PASTE.