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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

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COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH Back to Search Results
Model Number 5195501000
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Anxiety (2328); Distress (2329); Deformity/ Disfigurement (2360); Urinary Incontinence (4572)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.The date of revision was estimated.
 
Event Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pain with daily activities, infections, scarring, physical deformity, severe emotional pain, apprehension of increased risk of injuries, device exposure, discharge and surgical revision of the device.
 
Manufacturer Narrative
Correction: item number, health impact code.Additional information: lot number al100095.Deleted: udi number.The lot number was reviewed for complaint trend, nonconforming (nc) report, and capa.No ncs nor capas were identified.Devices met specification.
 
Event Description
Additional information received on 1/30/2023 as follows: on (b)(6) 2021 the patient was experiencing urgency of urination and on (b)(6) 2021 the patient underwent excision of the aris vaginal mesh.
 
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Brand Name
ARIS TRANSOBTURATOR KIT
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usbes brian e schmidt
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key16081054
MDR Text Key306493224
Report Number2125050-2022-01450
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/06/2023
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 Health Professional
Device Model Number5195501000
Device Catalogue Number519551
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received12/31/2022
Supplement Dates Manufacturer Received01/30/2023
Supplement Dates FDA Received02/06/2023
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) Required Intervention;
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