FDA Adverse Event
Injury
Summary report: N
SPEEDICATH CH14 MALE
MDR report key: 2925057
·
Received January 22, 2013
Report
- Report Number
- 3006606901-2013-00003
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 21, 2012
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K023254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
(B)(4). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED BLOOD IN HIS URINE. THE USER THOUGHT THAT THE CATHETER DID NOT HAVE A SMOOTH TIP WHICH CAUSED HIM TO BLEED. HE ALSO REPORTED DIFFCULTY WHEN INSERTING THE CATHETER AND MIGHT HAVE A STRICTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29858 | SPEEDICATH CH14 MALE | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 2841401400 | 3424668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |