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

Catalog Number	ENSMS002
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erosion (1750); Necrosis (1971); Skin Tears (2516); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2025
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.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 that the critical care nurses reported in an online survey stated physician stated that the patient experienced an adverse event directly attributable to the device enfit dignishield® stool management system with product code ensms002, and the patient experienced tissue injury(necrosis, tears, erosion, perforation, bleeding) and it did not result in patient injury requiring medical or surgical intervention.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states, contraindications: do not use for more than 29 consecutive days.The uninterrupted use for this device, including immediate replacement with the same or an identical device, is intended to be 29 days or less.Do not use on patients known to be sensitive to or allergic to any components within the system.Do not use on patients who had lower large bowel or rectal surgery within the last year.Do not use on patients with any rectal or anal injury, severe rectal or anal stricture or stenosis (or on any patient if the distal rectum cannot accommodate the inflated cuff), confirmed rectal or anal tumor, severe hemorrhoids, or fecal impaction.Do not use on patients with suspected or confirmed rectal mucosa impairment, i.E.Severe proctitis, ischemic proctitis, mucosal ulcerations.Do not use on patients with indwelling rectal or anal device (e.G.Thermometer) or delivery mechanism (e.G.Suppositories) or enemas in place.A dhr could not be performed since no lot number was provided.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 that the critical care nurses reported in an online survey stated physician stated that the patient experienced an adverse event directly attributable to the device enfit dignishield® stool management system with product code ensms002, and the patient experienced tissue injury(necrosis, tears, erosion, perforation, bleeding) and it did not result in patient injury requiring medical or surgical intervention.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH ENFIT¿
• 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: 24378847
• Report Number: 1018233-2026-00920
• Device Sequence Number: 10257930
• Product Code: KNT
• UDI-Device Identifier: 00801741113147
• UDI-Public: (01)00801741113147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENSMS002
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/09/2026
• 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