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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Missing Value Reason (3192)
Patient Problems Death (1802); Emotional Changes (1831); Lymphoma (3263)
Event Type  Death  
Manufacturer Narrative
(b)(4).Lawyer-filed report.
 
Event Description
It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death reported were cardiorespiratory distress and stage 4 lymphoma.Related to manufacturer report #: 2183959-2014-37242.
 
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Brand Name
AMS MINIARC SLING SYSTEM
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 Key5127523
MDR Text Key27457257
Report Number2183959-2014-37237
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Report Date 04/22/2013
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 Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2015
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 Initial
Patient Sequence Number1
Treatment
PERIGEE
Patient Outcome(s) Death;
Patient Weight90
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