MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE WITH ALOE SHORT SHEATH; MEC

Catalog Number 2283

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported that the user was unable to use his box of sheaths as the adhesive was really sticky and messy.The customer stored the sheaths in a cool dry place.

Event Description

It was reported that the user was unable to use his box of sheaths as the adhesive was really sticky and messy.The customer stored the sheaths in a cool dry place.

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: ¿the sheath is a strapless penile sheath; it has an adhesive coating inside to ensure a safe and simple procedure for fitting.".

• Brand Name: ROCHESTER CLEAR ADVANTAGE WITH ALOE SHORT SHEATH
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8607937
• MDR Text Key: 145092495
• Report Number: 1018233-2019-02500
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 2283
• Device Lot Number: JUCV0074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1