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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; BARE-METAL URETHRAL STENT, SHORT-TERM
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MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; BARE-METAL URETHRAL STENT, SHORT-TERM Back to Search Results
Model Number WA2ITA00
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Urinary Retention (2119); Hematuria (2558)
Event Date 11/14/2022
Event Type  Injury  
Event Description
The customer reports after an itind removal procedure, the patient returned a few hours after removal, with complaints of urinary retention.A 16fr foley catheter was placed and 480 ml of red colored urine was drained.Patient will return at a later date to have catheter removed.No further consequences to the patient were reported.Representative procode mer chosen in field.Actual procode qka for itind.
 
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Brand Name
ITIND, WITH SNARE, STERILE
Type of Device
BARE-METAL URETHRAL STENT, SHORT-TERM
Manufacturer (Section D)
MEDI-TATE LTD.
17 hauma street
hadera, israel 38501 69
IS  3850169
MDR Report Key15971420
MDR Text Key305381525
Report Number2429304-2022-00166
Device Sequence Number1
Product Code MER
UDI-Device Identifier07290015518062
UDI-Public07290015518062
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2022,12/13/2022
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? No
Device Operator Health Professional
Device Model NumberWA2ITA00
Device Lot NumberU1S02052022-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/14/2022
Event Location Hospital
Date Report to Manufacturer11/14/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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