FDA Adverse Event
Other
Summary report: N
LUBE JELLY
MDR report key: 2020206
·
Received March 7, 2011
Report
- Report Number
- 2128643-2011-00005
- Event Type
- Other
- Date Received
- March 7, 2011
- Report Date
- March 3, 2011
- Product Code
- FHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONSUMER SAID SHE WOULD CALL BACK AFTER DOCTOR VISIT AND NO RETURN PHONE CALL WITH PERMISSION TO SPEAK TO THE DOCTOR (B)(6) GIVEN. WE NEED TO GET THE FOLLOWING INFORMATION TO COMPLETE THE INVESTIGATION AND PERMISSION TO GET INFORMATION FROM THE DOCTOR. PRODUCT CODE AND LOT #, ANY RETURNED SAMPLES, COPIES OF ANY TEST RESULTS.
Description of Event or Problem · 1
PHONE CALL RECEIVED (B)(6) 2011 ABOUT RECALL OF LUBE JELLY. SHE HAS BEEN ON ANTIBIOTICS DUE TO INFECTIONS. SHE WILL BE RETURNING TO THE DOCTOR THIS WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUBE JELLY | FHX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATHETER CHANGE TWICE A DAY FOR OVER A YEAR |