MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE; MEC

Catalog Number	5283
Health Effect - Clinical Code	Injury (2348)
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 product had too much adhesive; the adhesive stuck to the patient's hair and pulled on it making the patient sore.
Additional 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 state 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." 1420, 2199: "nl".
Event or Problem Description
It was reported that the product had too much adhesive; the adhesive stuck to the patient's hair and pulled on it making the patient sore.

• Brand Name: ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7046665
• Report Number: 1018233-2017-06021
• Device Sequence Number: 1210875
• Product Code: NNX
• UDI-Device Identifier: 00801741071577
• UDI-Public: (01)00801741071577
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: Lay User/Patient
• Device Catalogue Number: 5283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1