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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING; URINARY INCONTINENCE SLING
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HERNIAMESH SRL T-SLING; URINARY INCONTINENCE SLING Back to Search Results
Model Number 5194001400
Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 05/20/2013
Event Type  Injury  
Manufacturer Narrative
Not returned.
 
Event Description
Plaintiff implanted with t-sling 5194001400 on (b)(6) 2009.Mesh removal occurred on 12:00:00 am.Patient's legal representative stated pain, erosion, extrusion, infection, bleeding, urinary problems, dyspareunia.
 
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Brand Name
T-SLING
Type of Device
URINARY INCONTINENCE SLING
Manufacturer (Section D)
HERNIAMESH SRL
via fratelli meliga 1/c
chivasso, torino 10034
IT  10034
Manufacturer (Section G)
HERNIAMESH SRL
via fratelli meliga 1/c
chivasso, torino 10034
IT   10034
Manufacturer Contact
selanna martorana
via fratelli meliga 1/c
chivasso, torino 10034
IT   10034
9011919623
MDR Report Key6095342
MDR Text Key59753039
Report Number9614846-2016-00223
Device Sequence Number1
Product Code PAH
UDI-Device Identifier28032919892120
UDI-Public28032919892120
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5194001400
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization; Required Intervention; Disability;
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