Description of Event or Problem · 1
FLUID FILLED BLISTER, BRUISES, "IT WAS LIKE IT WAS PINCHING HER" [BLISTER] CASE DESCRIPTION: NON-SERIOUS. THIS CASE IS A SPONTANEOUS REPORT REFERRING TO A FEMALE PATIENT OF AN UNKNOWN AGE. THE MOTHER OF THE PATIENT REPORTED THIS CASE. NO PAST MEDICAL HISTORY, CONCURRENT ILLNESSES, ALLERGIES OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT INITIATED NUTROPIN AQ (DOSE, FREQUENCY AND ROUTE NOT REPORTED) VIA NUTROPIN AQ PEN FOR AN UNKNOWN INDICATION. THE LOT NUMBER WAS NOT REPORTED. THE FIRST PUNCTURE DATE OF THE UNKNOWN LOT NUMBER WAS NOT REPORTED. THE PATIENT'S PRIOR HISTORY OF EXPOSURE TO THE UNKNOWN LOT NUMBER WAS NOT REPORTED. THE DATE OF LAST ADMINISTRATION WAS NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED FLUID FILLED BLISTERS, BRUISES, "IT WAS LIKE IT WAS PINCHING HER" (BLISTERS). RELEVANT LABORATORY TESTS AND TREATMENT WERE NOT REPORTED. THE MOTHER OF THE PATIENT REPORTED "OH, WE HAVE NOT DONE THE NUTROPIN FOR A REALLY LONG TIME. THE DOCTOR TOOK HER OFF OF THAT AND PUT HER BACK ON GENOTROPIN BECAUSE THE NUTROPIN CAUSED HER TO HAVE BLISTERS AND BRUISES." THE MOTHER REPORTED THAT SHE WAS USING ONE OF THE SHIELDS. SHE DID NOT CONFIRM WHICH SHIELD. SHE STATED THAT SHE HAD SHIPPED IT BACK TO MFR. SHE ALSO REPORTED THAT SHE DID NOT HAVE THE PEN ANYMORE AND THAT SHE HAD SHIPPED "ALL OF THE STUFF BACK". THE PATIENT DISCONTINUED USE WITH THE UNKNOWN LOT NUMBER OF NUTROPIN AQ. THE PATIENT'S RESPONSE TO THE GENOTROPIN WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE NON HEALTH PROFESSIONAL DID NOT PROVIDE A CAUSALITY ASSESSMENT OF THE EVENT BLISTERS IN RELATION TO NUTROPIN AQ. IN THE REPORTER'S OPINION, OTHER POSSIBLE ETIOLOGICAL FACTORS INCLUDED THE NUTROPIN AQ PEN. THIS CASE WAS IDENTIFIED AS A PRODUCT COMPLAINT AND PCS # HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PHARMACOVIGILANCE: BLISTER IS UNLABELED IN THE USPI AND UNEXPECTED IN THE IB FOR NUTROPEN AQ AND PEN. A SPONTANEOUS REPORT OF FLUID FILLED BLISTERS, BRUISES OCCURRING AFTER INITIATING NUTROPIN AQ VIA NUTROPIN AQ PEN ADMINISTERED FOR AN UNKNOWN INDICATION IN A FEMALE PATIENT OF AN UNKNOWN AGE. THIS NONSERIOUS EVENT IS ASSOCIATED TO A PRODUCT COMPLAINT.