FDA Adverse Event
Injury
Summary report: N
FOLEY CATHETER, 16F, SILVER
MDR report key: 3716128
·
Received March 21, 2014
Report
- Report Number
- 1417592-2014-00035
- Event Type
- Injury
- Date Received
- March 21, 2014
- Date of Event
- February 24, 2014
- Report Date
- March 20, 2014
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- NWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE END USER STATED THAT WHILE SHOWERING, THE CATHETER'S BALLOON RUPTURED AND THE CATHETER HAD TO BE REPLACED. THE CATHETER HAD BEEN INSERTED 10 DAYS PRIOR TO THE INCIDENT. NO ISSUES WERE IDENTIFIED DURING THAT TIME. THE NEW CATHETER WAS INSERTED AND NO INJURY WAS REPORTED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS REPORTED. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE.
Description of Event or Problem · 1
THE CATHETER BALLOON RUPTURED AND A NEW CATHETER WAS INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168119 | FOLEY CATHETER, 16F, SILVER | NWR | MEDLINE INDUSTRIES, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |