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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE TEMP-SENSING CATHETER; TEMPERATURE SENSING FOLEY PROBE
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE TEMP-SENSING CATHETER; TEMPERATURE SENSING FOLEY PROBE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Urinary Tract Infection (2120)
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 due to fever and wbc trending up, a urine culture was done and it was noted that the patient had a urinary tract infection.The patient was reportedly started on ceftriaxone 1gm every 24 hours.
 
Event Description
It was reported that due to fever and wbc trending up, a urine culture was done and it was noted that the patient had a urinary tract infection.The patient was reportedly started on ceftriaxone 1gm every 24 hours.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Since the product family is unknown, bard is unable to determine the associated labeling to review.
 
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Brand Name
UNKNOWN SILICONE TEMP-SENSING CATHETER
Type of Device
TEMPERATURE SENSING FOLEY PROBE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9320993
MDR Text Key166348745
Report Number1018233-2019-07321
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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