MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)

Catalog Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 03/13/2018

Event Type  Injury  

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 patient allegedly experienced a "deep tissue pressure injury" in the mucosal tissue; therefore, a wound consult was completed, the device removed, and barrier cream applied to the outer anal skin.The patient was rotated every couple of hours, the device was inserted on (b)(6) 2018 and removed on (b)(6) 2018 when the injury was noticed, and the mucosal pressure injury was semi-circular in shape.It was noted that no bleeding occurred and the mucosal injury was described as "1x1x0 injury to the inferior perianal area." clinical statement: barrier creams are over the counter medications.(b)(6) rn.

Event Description

It was reported that the patient allegedly experienced a "deep tissue pressure injury" in the mucosal tissue; therefore, a wound consult was completed, the device removed, and barrier cream applied to the outer anal skin.The patient was rotated every couple of hours, the device was inserted on (b)(6) 2018 and removed on (b)(6) 2018 when the injury was noticed, and the mucosal pressure injury was semi-circular in shape.It was noted that no bleeding occurred and the mucosal injury was described as "1x1x0 injury to the inferior perianal area." clinical statement: barrier creams are over the counter medications.Tschlager, rn.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this fecal management system product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the fecal management system product ifus are found to be adequate based on past reviews.The device was not returned.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7447803
• MDR Text Key: 106135313
• Report Number: 1018233-2018-01257
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 60