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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS PERIGEE SYSTEM; SURGICAL MESH
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ASTORA WOMEN'S HEALTH LLC AMS PERIGEE SYSTEM; SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Incontinence (1928)
Event Type  Injury  
Event Description
It was reported that after a perigee was implanted, the patient experienced mesh erosion and persistent stress incontinence.It was noted that the device malfunctioned.The patient underwent mesh removal on (b)(6) 2014.The patient was discharged.No further patient complications were reported.Related to manufacturer report #: 3011770902-2015-00114.Related to manufacturer report #: 3011770902-2015-00115.
 
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Brand Name
AMS PERIGEE SYSTEM
Type of Device
SURGICAL MESH
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
9522383906
MDR Report Key5335962
MDR Text Key34707674
Report Number3011770902-2015-00113
Device Sequence Number1
Product Code OTP
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 Other Health Care Professional
Type of Report Initial
Report Date 12/21/2015
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2015
Initial Date FDA Received12/30/2015
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
MONARC
Patient Outcome(s) Hospitalization; Required Intervention;
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