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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD INLAY OPTIMA URETERAL STENT
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PRODUCTOS PARA EL CUIDADO DE LA SALUD INLAY OPTIMA URETERAL STENT Back to Search Results
Catalog Number 788626
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2015
Event Type  malfunction  
Event Description
It was reported that before use on the patient, the physician noted the stent had a tear in it.The stent returned for investigation was broken.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of 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 bard.
 
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Brand Name
INLAY OPTIMA URETERAL STENT
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
nogales, sonora
MX 
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
km.7 carretera int'l
nogales, sonora 8562 1
MX   85621
Manufacturer Contact
christy lewis
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key4798456
MDR Text Key18089532
Report Number1018233-2015-00156
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeKN
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Physician
Type of Report Initial
Report Date 04/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number788626
Device Lot NumberNGYH3370
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/29/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/29/2015
Initial Date FDA Received05/22/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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