MAUDE Adverse Event Report: ROCHESTER MEDICAL CORP 2130787 ROCHESTER MEC WIDEBAND M 30BX

Catalog Number 36302

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ROCHESTER MEC WIDEBAND M 30BX
• Type of Device: MEC
• Manufacturer (Section D): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer (Section G): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6029753
• MDR Text Key: 57440483
• Report Number: 1018233-2016-01401
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 36302
• Device Lot Number: 53427731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention