FDA Adverse Event
Malfunction
Summary report: N
SPEEDICATH CH14 MALE 30PS
MDR report key: 1891313
·
Received November 4, 2010
Report
- Report Number
- 9610694-2010-00015
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Report Date
- January 21, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K023254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT 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.
Description of Event or Problem · 1
(B)(4). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH EYELETS THAT WERE ONLY PARTLY PUNCHED. SEVEN BOXES ALSO HAD CATHETERS IN WHICH THE TIPS WERE BADLY BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDICATH CH14 MALE 30PS | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 2841401404 | 2099217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |