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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH
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COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH Back to Search Results
Model Number 5195512400
Device Problem Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Pocket Erosion (2013); Injury (2348); Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).This one patient was implanted with two coloplast devices.The other device is captured in 2125050-2020-00465.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast though not verified, patient's legal representative stated foreign body reaction, pain, erosion of the mesh, urinary problems, vaginal bleeding and other injuries, impairment, permanent injury.
 
Event Description
Additional information reported to coloplast though not verified, indicated dyspareunia.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
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Brand Name
ARIS TRANS-OBTURATOR KIT
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key10169540
MDR Text Key195613080
Report Number2125050-2020-00464
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K050148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5195512400
Device Catalogue Number519551
Device Lot Number1670890
Was Device Available for Evaluation? No
Date Manufacturer Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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