MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE WITH ALOE STANDARD L 30BX; MEC

Catalog Number	1363
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the male external catheter was difficult to unroll.The patient believes there was too much adhesive.The patient experienced discomfort.No medical intervention reported.
Additional Manufacturer Narrative
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 were found adequate and state the following: ¿to remove: the sheath may be removed by gently rolling it off the penis.Avoid simply pulling the sheath off.Removing the sheath whilst having a bath of shower may increase comfort.".
Event or Problem Description
It was reported that the male external catheter was difficult to unroll.The patient believes there was too much adhesive.The patient experienced discomfort.No medical intervention reported.

• Brand Name: ROCHESTER CLEAR ADVANTAGE WITH ALOE STANDARD L 30BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8189528
• Report Number: 1018233-2018-06122
• Device Sequence Number: 2178652
• Product Code: NNX
• UDI-Device Identifier: 00801741070327
• UDI-Public: (01)00801741070327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 1363
• Device Lot Number: JUBT1731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1