MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-03-22 for TRIAD STERILE LUBRICATING JELLY 1003049 manufactured by Triad.
[1880773]
Received mail on (b)(6) 2011 cover letter and customer incident report defective product claim: the following information is from that form: customer had received insertion tray that was recalled due to triad lubricating jelly. Nurse called in and said she just got a defective letter today ((b)(6) 2011) for this patient that passed away in (b)(6) from infection. Further information received via phone call from (b)(6) - trustee for estate. She died (b)(6), 2010 of septic shock probably from uti.
Patient Sequence No: 1, Text Type: D, B5
[9179010]
According to phone conversation with trustee/caregiver ((b)(6)), the death certificate stated she died of: septic shock, multiple utis, cancer.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2128643-2011-00018 |
MDR Report Key | 2040811 |
Report Source | 00,07 |
Date Received | 2011-03-22 |
Date of Report | 2011-03-18 |
Date of Event | 2010-08-28 |
Date Mfgr Received | 2011-03-08 |
Date Added to Maude | 2011-04-08 |
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 | TRIAD STERILE LUBRICATING JELLY |
Generic Name | LUBE JELLY |
Product Code | FHX |
Date Received | 2011-03-22 |
Catalog Number | 1003049 |
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. Death; 2. Hospitalization | 2011-03-22 |