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MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE XL
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HOLOGIC, INC. MYOSURE XL
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Model Number
50-501XL
Device Problem
Fluid/Blood Leak (1250)
Patient Problem
No Information (3190)
Event Date
03/08/2018
Event Type
malfunction
Event Description
As per the incident report filed "during use of disposable myosure, the sterile team noticed fluid dripping from the myosure cord into the generator to w/c it is attached." intramural, submucous and subserous leiomyoma.
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Brand Name
MYOSURE XL
Type of Device
MYOSURE XL
Manufacturer
(Section D)
HOLOGIC, INC.
MDR Report Key
7421133
MDR Text Key
105290576
Report Number
MW5076421
Device Sequence Number
1
Product Code
HIH
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Unknown
Type of Report
Initial
Report Date
03/29/2018
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
Device Model Number
50-501XL
Device Catalogue Number
50-501XL
Device Lot Number
16M22RA
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
Yes
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
04/10/2018
Was Device Evaluated by Manufacturer?
No Information
Type of Device Usage
N
Patient Sequence Number
1
Patient Age
45 YR
Patient Weight
79
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