FDA Adverse Event
Other
Summary report: N
SCHEIN STERILE LUBE JELLY 4OZ TUBE
MDR report key: 2020218
·
Received March 7, 2011
Report
- Report Number
- 2128643-2011-00010
- Event Type
- Other
- Date Received
- March 7, 2011
- Date of Event
- December 27, 2010
- Report Date
- March 3, 2011
- Manufacturer
- TRIAD
- Product Code
- KMJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING OF RETAIN SAMPLES FOR ALL LOT NUMBERS AND WAITING FOR SAMPLES TO BE RETURNED FOR TESTING HAVE NOT BEEN COMPLETED AS OF (B)(6) 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. SEE SCANNED PAGES.
Description of Event or Problem · 1
E-MAIL NOTIFICATION ON (B)(6) 2011 OF INFECTION BY PSEUDOMONAS REPORTED AFTER CYSTOSCOPY. SYMPTOMS INCLUDE: RIGORS, MALAISE, JOINT PAIN AND DYSURIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCHEIN STERILE LUBE JELLY 4OZ TUBE | LUBE JELLY | KMJ | TRIAD | 19-8919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | CYSTOSCOPY |