OtherFHX
SCHEIN STERILE LUBE JELLY 4OZ TUBE
Received Mar 7, 2011 · Event occurred Dec 30, 2010
Report 2128643-2011-00007 · MDR key 2020207
Product problems
- Insufficient Device Problem Information
Patient
79 YR
- Bacterial Infection
- Muscle Spasm(s)
- Arthralgia
- Malaise
- Dysuria
Narrative
Additional Manufacturer Narrative
TESTING OF RETAIN SAMPLES FOR ALL LOT NUMBERS AND WAITING FOR SAMPLES TO BE RETURNED FOR TESTING HAVE NOT BEEN COMPLETED AS OF (B)(4) 2011. POSSIBLE LOT NUMBERS WHICH ARE BEING TESTED ARE: 0K71, 0K248, 0K137, 0G119. WITH SPECIFIC MICRO ANALYSIS FOR PSEUDOMONAS. LOT 0G119 WAS TESTED PREVIOUSLY ((B)(4) 2011) AND THE TESTING CAME BACK WITHIN SPECIFICATION AND NOTHING DETECTED DURING MICRO TESTING.
Description of Event or Problem
E-MAIL NOTIFICATION ON (B)(6) 2011 OF INFECTION BY PSEUDOMONAS REPORTED AFTER CYSTOSCOPY. SYMPTOMS INCLUDE: RIGORS, MALAISE, JOINT PAIN AND DYSURIA.