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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 5194101400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Purulent Discharge (1812)
Event Date 10/04/2016
Event Type  Injury  
Manufacturer Narrative
Not returned.
 
Event Description
Patient's legal representative stated hypertrophic vaginal tissue, pyuria, exposed suburethral mesh, ui, dissolving stitches inrt anterior vaginal wall, pyuria, foul vaginal odor.
 
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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 Key6215244
MDR Text Key63610015
Report Number9614846-2016-00250
Device Sequence Number1
Product Code PAH
UDI-Device Identifier28032919892120
UDI-Public28032919892120
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/29/2014
Device Model Number5194101400
Device Lot Number0672
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2016
Initial Date FDA Received12/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2009
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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