GEM 21S
Received Sep 27, 2012
Report 2410375-2012-00003 · MDR key 2855517
Device
Generic name
None
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Bacterial Infection
Narrative
Description of Event or Problem
ON (B)(6) 2012, A SPONTANEOUS REPORT WAS RECEIVED BY LUITPOLD PHARMACEUTICALS, INC. INVOLVING GEM 21S AND AN UNSPECIFIED PT. DURING F/U TO A PREVIOUSLY REPORTED ADVERSE REACTION INVOLVING GEM 21S ((B)(4)), A DENTAL PROVIDER REPORTED A SECOND HAND ACCOUNT THAT HER COLLEAGUE STATED HE HAD A PT WHO HAD EXPERIENCED "SYMPTOMS SIMILAR TO FLESH EATING BACTERIA" ((B)(6) CODED: BACTERIAL INFECTION NOS). SHE STATED HER COLLEAGUE USED GEM 21S OFF LABEL WITH THIS PT ((B)(6) CODED: OFF LABEL USE). NO ADDITIONAL INFO WAS AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFO RECEIVED (B)(6) 2012 FROM REPORTING (NON-TREATING) DENTAL PROVIDER: AFTER MULTIPLE REQUESTS TO THE REPORTER FOR THE NAME AND CONTACT INFO OF TREATING DENTIST, THE REPORTER RESPONDED THAT SHE WOULD NOT BE PROVIDING THE REQUESTED INFO, CITING "DOCTOR TO DOCTOR CONFIDENTIALITY," AND STATED THAT "MY COLLEAGUE ASSURED ME THAT HE SPOKE WITH YOUR COMPANY." NO ADDITIONAL INFO WAS PROVIDED, AND ON THE BASIS OF THIS RESPONSE, ADDITIONAL INFO WAS NOT EXPECTED FOR THIS CASE.