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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
Health Effect - Clinical Codes Urinary Retention (2119); Hematuria (2558)
Date of Event 11/14/2022
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
BARE-METAL URETHRAL STENT, SHORT-TERM
Manufacturer (Section D)
MEDI-TATE LTD.
17 hauma street
hadera, israel 38501 69
IS  3850169
MDR Report Key15971420
Report Number2429304-2022-00166
Device Sequence Number4938489
Product Code MER
UDI-Device Identifier07290015518062
UDI-Public07290015518062
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/13/2022
Report Date (Section F) 11/14/2022
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
Operator of Device 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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/13/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexMale
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