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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLINICAL RESEARCH CONSULTANTS, INC. SELF-THREADING MONOKA; PLUG, PUNCTUM
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CLINICAL RESEARCH CONSULTANTS, INC. SELF-THREADING MONOKA; PLUG, PUNCTUM Back to Search Results
Catalog Number S1.1800U
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Event Description
Provider placed the stent in the left eye.The stent was not in the correct position and was removed.A replacement stent was requested.When comparing the two stents (#s1.1800u reference number), there was a significant difference in length of the peek (polyetheretherketone) thread guide.The difference in length from the ex-planted stent and the newly opened stent was 155 mm.Unused stent with the same lot number (#1754308028) was the incorrect length.Manufacturer response for stent monoka self threading, self-threading monoka (ritleng type) (per site reporter): no response yet.
 
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Brand Name
SELF-THREADING MONOKA
Type of Device
PLUG, PUNCTUM
Manufacturer (Section D)
CLINICAL RESEARCH CONSULTANTS, INC.
3308 jefferson ave
cincinnati OH 45220
MDR Report Key7792979
MDR Text Key117467174
Report Number7792979
Device Sequence Number1
Product Code LZU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/19/2018,07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberS1.1800U
Device Lot Number1754308028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2018
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer08/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age960 DA
Patient Weight12
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