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

Catalog Number 2283

Device Problem Sticking (1597)

Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104)

Event Date 06/20/2017

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 by a patient that yesterday the clear advantage sheath stuck together preventing urine flow.It was later reported that the patient alleged to be in complete agony and was in tears from the pain.He stated he had to use scissors to relieve it.The patient alleged that this has deformed his foreskin, and caused his penis to swell due to the pressure.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "place rolled end over the end of the penis leaving a small space between the end of the penis and the cup o the sheath., if uncircumcised do not retract the foreskin but allow it to remain over the glans.Avoid contact between the adhesive and the glans.Slowly unroll the sheath along the shaft of the penis, then gently squeeze the sheath around the penis to ensure even adhesion.Try to avoid leaving a rolled 'collar' of sheath around the bas e of the penis." (b)(4).

Event Description

It was reported by a patient that yesterday the clear advantage sheath stuck together preventing urine flow.It was later reported that the patient alleged to be in complete agony and was in tears from the pain.He stated he had to use scissors to relieve it.The patient alleged that this has deformed his foreskin, and caused his penis to swell due to the pressure.

• Brand Name: ROCHESTER CLEAR ADVANTAGE WITH ALOE SHORT SHEATH M 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6699928
• MDR Text Key: 79572024
• Report Number: 1018233-2017-03611
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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