MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,08 report with the FDA on 2011-03-07 for SCHEIN STERILE LUBE JELLY 4OZ TUBE 19-8919 manufactured by Triad.
[1920553]
E-mail notification on (b)(6) 2011 of infection by pseudomonas reported after cystoscopy. Symptoms include: rigors, malaise, joint pain and dysuria.
Patient Sequence No: 1, Text Type: D, B5
[8832058]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2128643-2011-00007 |
| MDR Report Key | 2020207 |
| Report Source | 00,05,08 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-03 |
| Date of Event | 2010-12-30 |
| Date Mfgr Received | 2011-02-23 |
| Date Added to Maude | 2011-09-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTI BONAPARTE |
| Manufacturer Street | 700 NORTH SHORE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2625382900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHEIN STERILE LUBE JELLY 4OZ TUBE |
| Generic Name | LUBE JELLY |
| Product Code | FHX |
| Date Received | 2011-03-07 |
| Model Number | 19-8919 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIAD |
| Manufacturer Address | HARTLAND WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-07 |