ROCHESTER MEC WIDEBAND M 30BX
Report
- Report Number
- 1018233-2016-01401
- Event Type
- Injury
- Date Received
- October 14, 2016
- Date of Event
- September 26, 2016
- Report Date
- March 13, 2017
- Manufacturer
- ROCHESTER MEDICAL CORP 2130787
- Product Code
- NNX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
APPROX 11 UNOPENED SAMPLES WERE RECEIVED AT (B)(4) FOR EVALUATION. NO DEFECTS WERE FOUND DURING VISUAL EVALUATION, THE PACKAGES WERE UNOPENED AND THE PRINTED INFORMATION WAS CORRECT. PER THE FUNCTIONAL EVALUATION, AN ADHESIVE PEEL STRENGTH WAS PERFORMED TO PROVE THE FUNCTIONALITY OF THE ADHESIVE. THE ACCEPTABLE PEEL STRENGTH MUST BE IN A RANGE FROM 0.80 TO 2.80 LBF FOR A MEC 6030 WB 02 M 29MM. THE SAMPLES RESULTS WERE WITHIN THAT SPECIFICATION. THEREFORE, THE REPORTED EVENT WAS UNCONFIRMED AS THE PRODUCT MET SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "DIRECTIONS: TO APPLY: WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY; TRIM PUBIC HAIR IF NECESSARY; OPEN PACKAGE AT PERFORATION; TO REMOVE PLASTIC INSERT, SQUEEZE CATHETER AT THE TOP OF THE WHITE CONE AND PULL TO RELEASE; UNROLL SELF-ADHERING CATHETER OVER PENIS; GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN; CONNECT TO COLLECTION BAG. IMPORTANT: WEAR TIME MAY BE SIGNIFICANTLY REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN. DIRECTIONS: TO REMOVE GENTLY ROLL CATHETER OFF THE PENIS. NOTE: IF NECESSARY, APPLY A WARM WET COMPRESS (SUCH AS A WET WASHCLOTH) AROUND THE CATHETER TO HELP LOOSEN THE ADHESIVE." (B)(4). 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 CATHETER WAS STUCK TO THE PATIENT'S SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. ALLEGEDLY, AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL, IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE PATIENT'S SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. ALLEGEDLY, AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE PATIENT'S SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. ALLEGEDLY, AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL, IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
IT WAS REPORTED THAT THE CATHETER WAS STUCK TO THE PATIENT'S SKIN. IT WAS LATER REPORTED THAT THE DEVICE WAS IN PLACE FOR 11 HOURS. ALLEGEDLY, AFTER 20 MINUTES OF TRYING TO REMOVE THE CATHETER, UPON REMOVAL, IT WAS NOTED THAT A PORTION OF THE PATIENTS SKIN WAS ALSO REMOVED. WARM WATER AND SOAP WAS USED, AND LATER OIL. WHEN THE OIL WAS USED, THE SHEATH WAS REMOVED SUCCESSFULLY. THE ADHESIVE RESIDUE WAS STILL VISIBLE ON THE PENIS AND WAS HARD TO REMOVE. AS A RESULT, THE REPLACEMENT CATHETER ALSO STUCK TO THE PATIENTS SKIN. THERE WAS NO OTHER REPORTED INTERVENTION PERFORMED PRIOR TO THE PLACEMENT OF THE EXTERNAL CATHETER, AND THE SKIN WAS IN GOOD CONDITION BEFORE USE OF THE CATHETER. THERE WERE NO LESIONS AND THE HAIR WAS SHAVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681133 | ROCHESTER MEC WIDEBAND M 30BX | MEC | NNX | ROCHESTER MEDICAL CORP 2130787 | 53427731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |