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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DILATION PRODUCTS

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C.R. BARD, INC. (COVINGTON) -1018233 DILATION PRODUCTS Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
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 female patient had a percutaneous nephrostolithotomy where an x-force nephrostomy balloon dilating catheter was used on (b)(6) 2018. A ct scan on (b)(6) 2018 was being completed for other medical reasons not related. The scan revealed a foreign body which was asymptomatic to the patient and was a coincidental finding on ct scan. A ureteroscopy showed what appeared to be part of a sheath measuring 7x7mm which was not collapsible or foldable and could not be removed during the ureteroscopy. The foreign body was removed percutaneously. A double-j stent and foley catheter was left in place after the foreign body removal. The patient was admitted on (b)(6) 2018 as a 23 hour observation patient, post foreign body removal and started on cephalexin 500 mg by mouth three times a day and continued on the same antibiotic at discharge from hospital admission. The pathology report gross examination of the foreign object was as follows, "it is a 0. 9 x 0. 6 x 0. 1 cm curvilinear portion of plastic having a lime green colored outer diameter and a tan-light blue colored inner diameter. ".
 
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Brand NameDILATION PRODUCTS
Type of DeviceDILATION PRODUCTS
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8189743
MDR Text Key131166750
Report Number1018233-2018-06135
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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