COAPTITE M006890300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for COAPTITE M006890300 manufactured by Merz North America, Inc..

Event Text Entries

[111199937]
Patient Sequence No: 1, Text Type: N, H10


[111199939] The coaptite implant was hard to push through syringe and needle. Staff opened a second syringe with same lot number and then a third syringe with a different lot number. They all had the same issue. Staff opened the second needle and had the same issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7604942
MDR Report Key7604942
Date Received2018-06-15
Date of Report2018-06-06
Date of Event2018-05-23
Report Date2018-06-06
Date Reported to FDA2018-06-06
Date Reported to Mfgr2018-06-06
Date Added to Maude2018-06-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOAPTITE
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Product CodeLNM
Date Received2018-06-15
Catalog NumberM006890300
Lot Number100103908
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMERZ NORTH AMERICA, INC.
Manufacturer Address6501 SIX FORKS ROAD RALEIGH NC 27615 US 27615


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-15

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