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 |