MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

Catalog Number 35302

Device Problems Positioning Failure (1158); Nonstandard Device (1420)

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 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 device was not returned.

Event Description

It was reported that the sheaths were not staying on and allegedly caused the patient distress due to wetness.The patient also had problems with the sheaths not unrolling properly.

Event Description

It was reported that the sheaths were not staying on and allegedly caused the patient distress due to wetness.The patient also had problems with the sheaths not unrolling properly.

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 was found adequate and states the following: "fitting the sheath: the sheath is a strapless penile sheath: it has an adhesive coating inside to ensure a safe and simple procedure for fitting.If necessary trim pubic hair clean and dry pubic area remove sheath from its wrapping place rolled end over the end of the penis, leaving a small space between the end of the penis and the cup of 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 shad around the penis to ensure even adhesion.Try to avoid leaving a rolled 'collar' of sheath around the base of the penis.Finally, connect the urine collection bag.Always check that the connections are secure before use.Wear time will vary from user to user.It is recommended that a sheath b changed every 24 hours for reasons of hygiene.To remove : the sheath may be removed by gently tolling it off the penis.Avoid simply lulling the sheath off.Removing the sheath whilst having a bath or shower may increase comfort.Do not use on irritated or compromised skin.Discontinue use if irritation occurs." section a through f - 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.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7864487
• MDR Text Key: 120105338
• Report Number: 1018233-2018-04108
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: 35302
• Device Lot Number: JUCR0309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1