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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXAIR ANTERIOR KIT; SURGICAL MESH
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EXAIR ANTERIOR KIT; SURGICAL MESH Back to Search Results
Model Number 5010002400
Device Problems Device Appears to Trigger Rejection (1524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Emotional Changes (1831); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Chills (2191); Urinary Frequency (2275); Injury (2348); Malaise (2359); Fungal Infection (2419); Prolapse (2475); Blood Loss (2597); Dysuria (2684); No Known Impact Or Consequence To Patient (2692); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This mdr is created as a follow-up to record (b)(4), initially reported on product code otp asr exemption # e2014015 for april 2019 - may 15, 2019.This mdr is to reflect the additional patient information, date of birth, to be added to the "intial" asr report.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
This mdr is created as a follow-up to record (b)(4), initially reported on product code otp asr exemption # e2014015 for april 2019 - may 15, 2019.This mdr is to reflect the additional information to be added to the intial asr report.
 
Manufacturer Narrative
This follow-up was created to document the additional device information.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, additional information stated, the patient had recurrent uti's, urinary frequency, urinary hesitancy, nocturia, and incomplete emptying of bladder, urinary loss of control.On (b)(6) 2017 removal of eroded mesh with closure of defect under general anesthesia.Urinary tract infection, dysuria, continued incontinence, urge incontinence, exposure were also reported.The device was removed.
 
Manufacturer Narrative
This follow-up was created to document the additional event information recieved and updated, corrected h6 codes.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Manufacturer Narrative
Patient code 3191 is used for noctouria.Patient code 3190 is used for urinary hesitancy, new onset urinary and pelvic complications.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, additional information stated, urinary tract infection, dysuria, continued incontinence, urge incontinence, exposure were also reported.The device was removed.Additional information stated, scant vaginal discharge, dysuria, fever, body aches, uti, vaginal yeast infection.(b)(6) 2016 -ed visit for recurrent uti, malaise, nausea, fatigue, decreased appetite.(b)(6) 2017 - hospitalized for fever/chills, n/v, dark urine, "hurts all over", claimant stated has had recurrent uti's every 3-4 months since implants, uti.Exair palpated at anterior vagina.Hospitalized for urinary dysuria/frequency/urgency, n/v, low grade fever, recurrent uti, weak/slow/poor urinary stream, strain/bear down required to start urinary stream, incomplete bladder emptying, exair exposure toward bladder, erosion over bladder.(b)(6) 2017 - partial excision of eroded/exposed exair, cystocele repair, general anesthesia - pathology showed chronically inflamed squamous mucosa with admixed mesh material.Poor urinary stream, continued chronic cystitis, urinary frequency.(b)(6) 2014 - scant vaginal discharge, passed voiding trial, scant vaginal bleeding with yellow discharge, urinary frequency/nocturia, grade 1-2 rectocele, uti, (b)(6) 2019 - ed visit for uti (b)(6) 2019 - urinary frequency/nocturia, occasional difficulty starting stream/need to strain, decreased force of stream, stream starts/stops during void, severe postmenopausal atrophic vaginitis, no exair or desara exposure, some apex descensus.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
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Brand Name
EXAIR ANTERIOR KIT
Type of Device
SURGICAL MESH
MDR Report Key9765060
MDR Text Key188371403
Report Number2125050-2020-00177
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number5010002400
Device Catalogue Number501000
Device Lot Number4172247
Patient Sequence Number1
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