MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

Catalog Number	SMS002
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that the patient developed a rectal bleed.No medical intervention was reported.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states: precautions: if the patient¿s bowel control, consistency and frequency of stool begin to return to normal, discontinue use of the device.Caution should be exercised in using this device in patients who have a tendency to bleed from either anticoagulant or antiplatelet therapy or underlying disease.When using the tube clamp for medication delivery, ensure the patient is closely monitored and is not allowed to lie on the tube clamp.Ensure the tube clamp is only used during medication delivery and for the prescribed dwell time.Do not leave the tube clamp on the drainage tube for longer than the prescribed dwell time.Potential adverse events: as with the use of any rectal device, the following adverse events may occur: excessive leakage of stool around the device; loss of anal sphincter muscle tone which could lead to temporary or permanent anal sphincter dysfunction; pressure necrosis of rectal or anal mucosa.Infection: bowel obstruction; perforation of the bowel; rectal bleeding; rectal tear; ulceration of rectal or anal mucosa.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: a, d, e.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all 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 bd.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported by customer that patient developed a rectal bleed.No medical intervention was reported.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Common Device Name: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 25060122
• Report Number: 1018233-2026-02840
• Device Sequence Number: 15802506
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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 Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown