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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUNCTUAL PLUGS; PLUG, PUNCTUM
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PUNCTUAL PLUGS; PLUG, PUNCTUM Back to Search Results
Device Problem Activation Failure (3270)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Did not work; reported by hcp did consent to follow up (b)(6).
 
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Brand Name
PUNCTUAL PLUGS
Type of Device
PLUG, PUNCTUM
MDR Report Key16565428
MDR Text Key311572476
Report NumberMW5115795
Device Sequence Number1
Product Code LZU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Patient Sequence Number1
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