FDA Adverse Event
Other
Summary report: N
LUBRICATING JELLY - HENRY SCHEIN
MDR report key: 2020219
·
Received March 7, 2011
Report
- Report Number
- 2128643-2011-00002
- Event Type
- Other
- Date Received
- March 7, 2011
- Date of Event
- January 5, 2011
- Report Date
- March 5, 2011
- Manufacturer
- TRIAD
- Product Code
- KMJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUBRICATING JELLY - HENRY SCHEIN | NONE | KMJ | TRIAD | 19-8919 | 0G119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | USED DURING CIRCUMCISION |