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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD INLAY LUBRICIOUS URETERAL STENT
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PRODUCTOS PARA EL CUIDADO DE LA SALUD INLAY LUBRICIOUS URETERAL STENT Back to Search Results
Catalog Number 777626
Device Problems Break (1069); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2014
Event Type  malfunction  
Event Description
When the doctor opened the package they found one top of the stent was disconnected.Upon return of the sample it was found the stent was broken.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
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Brand Name
INLAY LUBRICIOUS 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 internacional
nogales, sonora 8562 1
MX   85621
Manufacturer Contact
christy lewis
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key4534632
MDR Text Key20151583
Report Number1018233-2015-00046
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K983498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/23/2015
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 Date04/30/2018
Device Catalogue Number777626
Device Lot NumberNGXH6511
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/23/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/13/2015
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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