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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
Device Problems Inadequate or Insufficient Training (1643); Insufficient Information (3190)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  Injury  
Event Description
It was reported that the hospital representative requested educational material on the dignishield and mentioned that they have had an issue that might have led to patient injury.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the hospital representative requested educational material on the dignishield and mentioned that they have had an issue that might have led to patient injury.No specifics were mentioned, as the representative was tasked within the hospital to create an education plan for the staff on dignishield.
 
Manufacturer Narrative
Per investigator evaluation, bd has determined that this mdr event is not reportable.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.H3 other text : the device was not returned.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text: the device was not returned.
 
Event Description
It was reported that the hospital representative requested educational material on the dignishield and mentioned that they have had an issue that might have led to patient injury.No specifics were mentioned, as the representative was tasked within the hospital to create an education plan for the staff on dignishield.It is unknown what medical intervention is provided.
 
Event Description
It was reported that the hospital representative requested educational material on the dignishield and mentioned that they have had an issue that might have led to patient injury.No specifics were mentioned, as the representative was tasked within the hospital to create an education plan for the staff on dignishield.It is unknown what medical intervention is provided.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause was not chosen due to a lack of information.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed due to a lack of information.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.H3 other text : the device was not returned.
 
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Brand Name
UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
Type of Device
UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15192334
MDR Text Key300444732
Report Number1018233-2022-06192
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 07/24/2023
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2022
Initial Date FDA Received08/09/2022
Supplement Dates Manufacturer Received10/28/2022
07/26/2022
07/24/2023
Supplement Dates FDA Received11/02/2022
07/20/2023
07/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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