FDA Adverse Event
Other
Summary report: N
DRAIN BAG W/SPLASHGUARD/ NO ANTIREFLUX
MDR report key: 2584569
·
Received May 17, 2012
Report
- Report Number
- 9612030-2012-00027
- Event Type
- Other
- Date Received
- May 17, 2012
- Report Date
- April 19, 2012
- Manufacturer
- COVIDIEN
- Product Code
- FCN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(6) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A UROLOGY DRAIN BAG. CUSTOMER REPORTS THAT THE URINE IS BACKING UP IN THE TUBING AND IS NOT DRAINING INTO THE BAG. THE CUSTOMER FURTHER REPORTS THAT A PT HAD INCREASED BLOOD PRESSURE AS A RESULT AND REQUIRED AN ADDITIONAL AMOUNT OF BLOOD PRESSURE MEDICATION TO BE ADMINISTERED; HOWEVER, THEY DO NOT KNOW THE NAME OF THE MEDICATION. THE PT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRAIN BAG W/SPLASHGUARD/ NO ANTIREFLUX | UROLOGY DRAIN BAG | FCN | COVIDIEN | 3057 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |