THIS INITIAL NON-SERIOUS SPONTANEOUS REPORT, WHICH ORIGINATED FROM THE UNITED STATES, WAS RECEIVED ON 15-SEP-2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT ON UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON (B)(6) 2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE SUBJECT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. ACTION TAKEN WITH NUVAGEN COLLAGEN POWDER WAS NOT REPORTED. OUTCOME OF THE EVENT 'PAIN AT WOUND SITE' WAS NOT REPORTED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. A PRODUCT QUALITY COMPLAINT WAS RAISED AND COMPLAINT SAMPLE WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.
D
Patient 1
THIS INITIAL NON-SERIOUS SPONTANEOUS REPORT, WHICH ORIGINATED FROM THE UNITED STATES, WAS RECEIVED ON 15-SEP-2017. INFORMATION HAS BEEN RECEIVED FROM A CONSUMER CONCERNING A FEMALE PATIENT ON UNSPECIFIED AGE WHO WAS USING NUVAGEN COLLAGEN POWDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WAS NOT PROVIDED. FROM AN UNSPECIFIED DATE THE PATIENT WAS USING NUVAGEN COLLAGEN POWDER (1 GM PACKET). BATCH NUMBER AND EXPIRY DATE WAS NOT PROVIDED. ON (B)(6) 2017, WHILE APPLYING NUVAGEN COLLAGEN POWDER, THE SUBJECT EXPERIENCED PAIN AT WOUND SITE. IT WAS REPORTED THAT THE PATIENT HAD WOUNDS BETWEEN HER TOES AND THE WOUNDS WERE SEVERE. WHEN THE CONSUMER APPLIED COLLAGEN POWDER TO HER MOTHER'S WOUNDS, THE PATIENT COULD NOT TOLERATE AS SHE HAD PAIN AT WOUND SITE. THE PATIENT RECEIVED ALGINATE WITH SILVER PER ORDER FROM DOCTOR. ACTION TAKEN WITH NUVAGEN COLLAGEN POWDER WAS NOT REPORTED. OUTCOME OF THE EVENT 'PAIN AT WOUND SITE' WAS NOT REPORTED. THE REPORTER STATED THAT DUE TO THE SEVERITY OF THE WOUNDS, ANY DRESSING WOULD HAVE CAUSED THE PAIN AT THE WOUND SITE AND THAT IT WAS NOT ACTUALLY RELATED TO THE COLLAGEN POWDER ITSELF. A PRODUCT QUALITY COMPLAINT WAS RAISED AND COMPLAINT SAMPLE WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.