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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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ASTORA WOMEN'S HEALTH LLC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/22/2015
Event Type  Injury  
Event Description
It was reported that during the implantation of a monarc sling on (b)(6) 2015 the "plastic grommet was lost" and a "piece of the sling was lost and unable to be located".An ultrasound was performed on (b)(6) 2015 and the physician was able to located the missing pieces.A revision was done the same day to remove the pieces.The patient was "doing well after foreign body removal".No further patient complications were reported in relation to this event.
 
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Brand Name
AMS MONARC SLING SYSTEM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASTORA WOMEN'S HEALTH LLC
13200 pioneer trail
suite 100
eden prairie MN 55347
Manufacturer (Section G)
ASTORA WOMEN'S HEALTH LLC
13200 pioneer trail
suite 100
eden prairie MN 55347
Manufacturer Contact
erika a. merrick
13200 pioneer trail
suite 100
eden prairie, MN 55347
MDR Report Key5232418
MDR Text Key31460827
Report Number3011770902-2015-00020
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/04/2015
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2015
Initial Date FDA Received11/18/2015
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
Patient Outcome(s) Hospitalization; Required Intervention;
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