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MAUDE Adverse Event Report: FILSHIE CLIPS
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FILSHIE CLIPS
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Device Problem
Patient-Device Incompatibility (2682)
Patient Problems
Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994)
Event Type
Injury
Event Description
Tubal ligation clamps, i was not given the dangerous or warnings.I have since suffered with abdominal pain, sharp pain, heavy bleeding, and i have not felt like myself since the procedure.
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Brand Name
FILSHIE CLIPS
Type of Device
FILSHIE CLIPS
MDR Report Key
7251079
MDR Text Key
99578078
Report Number
MW5075130
Device Sequence Number
1
Product Code
KNH
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Patient
Type of Report
Initial
Report Date
02/06/2018
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Was Device Available for Evaluation?
Yes
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
02/07/2018
Was Device Evaluated by Manufacturer?
No Information
Type of Device Usage
N
Patient Sequence Number
1
Patient Outcome(s)
Disability;
Patient Age
35 YR
Patient Weight
64
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