MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX

Model Number	39102
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a stage 3 pressure sore was observed at the base of the patient's penis after using the male external catheter.The complainant reported that this was treated with prescribed medication.Clinical statement: per reportability guidelines, it has been determined that this type of event has caused or contributed to a serious injury.It is likely that this type of injury may require medical intervention, although not reported at this time.To date, there has been no additional information provided regarding the reported additional medical treatment of prescribed medication.If additional information is received, the complaint and reportability will be updated accordingly.
Event or Problem Description
It was reported that a stage 3 pressure sore was observed at the base of the patient's penis after using the male external catheter.The complainant reported that this was treated with prescribed medication.Clinical statement: per reportability guidelines, it has been determined that this type of event has caused or contributed to a serious injury.It is likely that this type of injury may require medical intervention, although not reported at this time.To date, there has been no additional information provided regarding the reported additional medical treatment of prescribed medication.If additional information is received, the complaint and reportability will be updated accordingly.
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 states the following: "pop-on¿, self-adhering male external catheter, wideband¿, self-adhering male external catheter, spirit style 2 / style 3, hydrocolloid adhesive sheath.Description/indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Catalog number, lot number, manufacturer, authorized representative, units, non-sterile, single use, use by, not made, with natural, rubber latex.Caution: consult, accompanying, documents".

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7452503
• Report Number: 1018233-2018-01303
• Device Sequence Number: 931477
• Product Code: NNX
• UDI-Device Identifier: 00801741071287
• UDI-Public: (01)00801741071287
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 39102
• Device Catalogue Number: 39102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention