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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 Problem Insufficient Information (3190)
Patient Problem Incontinence (1928)
Event Date 11/07/2016
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
Patient's legal representative stated urinary incontinence, physical deformity and loss of the ability to enjoy life and perform sexually.
 
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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 Key6215307
MDR Text Key63611384
Report Number9614846-2016-00298
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 Date09/01/2017
Device Model Number5194001400
Device Lot Number0881
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/28/2016
Initial Date FDA Received12/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2012
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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