OtherFHX
LUBE JELLY
Received Mar 7, 2011
Report 2128643-2011-00005 · MDR key 2020206
Device
Generic name
Lube Jelly
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
CONSUMER SAID SHE WOULD CALL BACK AFTER DOCTOR VISIT AND NO RETURN PHONE CALL WITH PERMISSION TO SPEAK TO THE DOCTOR (B)(6) GIVEN. WE NEED TO GET THE FOLLOWING INFORMATION TO COMPLETE THE INVESTIGATION AND PERMISSION TO GET INFORMATION FROM THE DOCTOR. PRODUCT CODE AND LOT #, ANY RETURNED SAMPLES, COPIES OF ANY TEST RESULTS.
Description of Event or Problem
PHONE CALL RECEIVED (B)(6) 2011 ABOUT RECALL OF LUBE JELLY. SHE HAS BEEN ON ANTIBIOTICS DUE TO INFECTIONS. SHE WILL BE RETURNING TO THE DOCTOR THIS WEEK.