FDA Adverse Event
Injury
Summary report: N
BLADDER CARE TRAY KIT
MDR report key: 3841102
·
Received May 13, 2014
Report
- Report Number
- 1018233-2014-00100
- Event Type
- Injury
- Date Received
- May 13, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 17, 2014
- Manufacturer
- BARD SDN. BHD.
- Product Code
- EZC
- PMA / PMN Number
- K910846
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN EDUCATIONAL CLASS A NURSE PICKED UP A LATEX CATHETER. THE NURSE HAD A LATEX ALLERGY AND HAD AN ALLERGIC REACTION. THE NURSE HAD TAKEN BENADRYL, AS WELL AS GO TO THE ER. IT IS UNKNOWN IF A SECONDARY INTERVENTION WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285330 | BLADDER CARE TRAY KIT | EZC | BARD SDN. BHD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | NURSE WENT TO ED FOR FURTHER ASSESSMENT.| NURSE HAD TO TAKE BENADRYL AFTER HANDLING PRODUCT. |