INTERMITTENT MAGIC3 HYDRO
Report
- Report Number
- 1018233-2015-00243
- Event Type
- Injury
- Date Received
- July 31, 2015
- Report Date
- July 30, 2015
- Manufacturer
- ROCHESTER MEDICAL CORP.
- Product Code
- KOD
- PMA / PMN Number
- K000723
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "HOW TO PREPARE AND USE THE MAGIC 3 CATHETER. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE. MADE OF SILICONE ELASTOMER." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ECOLI IN THEIR BLADDER, URINE ODOR & ABDOMINAL PAIN AS A RESULT OF USING THE DEVICE. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC TO TREAT THE BLADDER PAIN. THE PATIENT HAS AN ADD'L DR'S VISIT SCHEDULED FOR (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499014 | INTERMITTENT MAGIC3 HYDRO | KOD | ROCHESTER MEDICAL CORP. | NA | 56321279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |