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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE
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C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE Back to Search Results
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Type  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 a piece of the wound drain was removed from the patient during a surgical procedure.The complainant was reportedly uncertain when the drain broke off in the patient.
 
Event Description
It was reported that a piece of the wound drain was removed from the patient during a surgical procedure.The complainant was reportedly uncertain when the drain broke off in the patient.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.
 
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Brand Name
WOUND DRAINAGE
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9410582
MDR Text Key169254972
Report Number1018233-2019-07684
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/13/2019
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
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/04/2019
Supplement Dates Manufacturer Received12/10/2019
Supplement Dates FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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