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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD) Back to Search Results
Catalog Number UNKNOWN
Device Problem Use of Device Problem (1670)
Patient Problems Tissue Damage (2104); Pressure Sores (2326)
Event Type  Injury  
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 Description
It was reported that the dignashield was filled with over 100ml and no one involved in the care of the patient, was aware of how that amount of water was placed into balloon.The complainant noted that all members of the are aware that the insertion amount is 45ml.This same patient was also found to have a st 3 (full thickness) pressure injury to the perirectal tissue, believed to be caused by the dignashield tubing.Venelex topical ointment was ordered.It was alleged that the tubing was frequently re-positioned and venelex was used to perirectal tissue twice daily.Per verification from medical services , the ifu advises to uses only 45ml of water.
 
Event Description
It was reported that the dignashield was filled with over 100ml and no one involved in the care of the patient, was aware of how that amount of water was placed into balloon.The complainant noted that all members of the are aware that the insertion amount is 45ml.This same patient was also found to have a st 3 (full thickness) pressure injury to the perirectal tissue, believed to be caused by the dignashield tubing.Venelex topical ointment was ordered.It was alleged that the tubing was frequently re-positioned and venelex was used to perirectal tissue twice daily.Per verification from medical services , the ifu advises to uses only 45ml of water.
 
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 unknown fecal management system product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the unknown fecal management system product labeling are found to be adequate based on past reviews.
 
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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 Key8544127
MDR Text Key142898890
Report Number1018233-2019-02145
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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