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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SLING; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

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ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SLING; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER Back to Search Results
Model Number UR31051002
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Neuropathy (1983); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Ambulation Difficulties (2544); Dysuria (2684); Constipation (3274); Suicidal Ideation (4429); Dyspareunia (4505); Sexual Dysfunction (4510)
Event Date 09/20/2022
Event Type  Injury  
Event Description
According to available information, this device required an emergency room visit due to pain.The patient felt intense pain in her vagina while sitting at workstation and was taken to the emergency room.She reports she is not able to work due to pain while sitting, not able to drive due to pain, has chronic pain with walking, burning in vagina, dyspareunia, takes neuropathic medication twice daily, and takes anti-depressants.She has two follow up appointments, one at the pain center and another for pelvic infiltration.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.The restorelle device referenced in b5 is captured under a separate manufacturing report number.
 
Event Description
The patient had two types pf prosthesis [restorelle and aris].Additional information was provided to coloplast, though not verified: immediately post restorelle and aris placement, the patient had favorable postoperative follow-up.Since the implant, the patient reportedly has also experienced abdominal and pelvic pain during sexual intercourse, difficulties with walking (moving in a wheelchair) and prolonged sitting; constipation; recurrent urinary tract infections; suicidal ideation; vagal discomfort and dysuria.The patient also reported that the slings were too tight (left side) causing the pain.An ultrasound of the aris reported asymmetrical positioning in an axial plane with a tight appearance on the left.Urethral erosion could not be formally eliminated.An explant procedure was performed on (b)(6) 2023.
 
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Brand Name
ARIS TRANSOBTURATOR SLING
Type of Device
FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
Manufacturer (Section D)
ABISS - ANALYTIC BIOSURGICAL SOLUTIONS
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
8007880293
MDR Report Key16017882
MDR Text Key305840252
Report Number2125050-2022-01416
Device Sequence Number1
Product Code OTN
UDI-Device Identifier03760150471231
UDI-Public3760150471231
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/17/2024
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 NumberUR31051002
Device Catalogue NumberUR3101
Device Lot NumberAT120112_UR31012022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2022
Initial Date FDA Received12/20/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/26/2020
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;
Patient Age53 YR
Patient SexFemale
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