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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. INFAST SLING; MESH, SURGICAL, POLYMERIC
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AMERICAN MEDICAL SYSTEMS, INC. INFAST SLING; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 72403612
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Neuropathy (1983); Pain (1994)
Event Date 02/28/2011
Event Type  Injury  
Manufacturer Narrative
Exemption-(b)(4.) total number of events summarized - (b)(4).Infast sling.
 
Event Description
It was reported by the plaintiff's attorney that the plaintiff experienced chronic pelvic or vaginal pain, pelvic floor neuropathy, urgency leakage and mixed urinary incontinence.The device remains implanted.No further complications have been reported in relation to this event.
 
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Brand Name
INFAST SLING
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd w
minnetonka MN 55343
Manufacturer (Section G)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd w
minnetonka MN 55343
Manufacturer Contact
erika merrick
10700 bren rd w
minnetonka, MN 55343
8442511068
MDR Report Key5146724
MDR Text Key28136360
Report Number2183959-2015-57784
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Report Date 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/25/2005
Device Catalogue Number72403612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age39 YR
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