MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2011-03-07 for LUBRICATING JELLY - HENRY SCHEIN 19-8919 manufactured by Triad.
[1919997]
It was reported on or around (b)(6) 2011 to dr. (b)(6) that dr. (b)(6) performed a circumcision on an infant patient. The patient was brought into the facility the following saturday because of an infection. The following day the infant was brought in again and then sent to the hospital via ambulance. The infant was moved from a local hospital to the (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9221769]
Addition microbial testing was requested on (b)(4) 2011 for pseudomonas and results were reported on (b)(4) 2011 as negative for that bacteria, no updated status as of (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2128643-2011-00002 |
| MDR Report Key | 2020219 |
| Report Source | 05,07,08 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-05 |
| Date of Event | 2011-01-05 |
| Date Mfgr Received | 2011-02-01 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-05-08 |
| 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 | LUBRICATING JELLY - HENRY SCHEIN |
| Generic Name | NONE |
| Product Code | KMJ |
| Date Received | 2011-03-07 |
| Model Number | 19-8919 |
| Lot Number | 0G119 |
| Device Expiration Date | 2013-07-01 |
| 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. Hospitalization | 2011-03-07 |