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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; SURGICAL MESH
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; SURGICAL MESH Back to Search Results
Lot Number AQC60046
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discomfort (2330); Fungal Infection (2419); Prolapse (2475); Blood Loss (2597); Dysuria (2684); No Information (3190); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for april-may 15, 2019.This mdr is to reflect the additional information to be added to the intial asr report.(explant date month/year).
 
Event Description
This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for april-may 15, 2019.This mdr is to reflect the additional information to be added to the intial asr report.Additional information received indicated the explant date month/year was (b)(6) 2018.
 
Event Description
Additional information reported to coloplast though not verified, indicated vaginal bleeding due to suture irritation, unable to urinate x 8 hours, worsening abdominal pain, catheterized for 1200 ml, acute urinary retention, bladder spasms, urinary retention/incomplete bladder emptying from constipation.Claimant stated she had to place finger into vagina in order to urinate, constant urinary leakage, changed pad 2x/day, required foley catheter and then self- intermittent catheterization, worsening chronic urethritis with worsening uui symptoms/nocturia, pressure, uti.(b)(6) 2017 - in-office cystoscopy & cystometrogram inflammatory polyps at bladder neck, worsening chronic urethritis causing dysuria and bladder spasms, aris in good position with no evidence of compression, candidiasis.(b)(6) 2017 - exam under anesthesia, urethroscopy, cystoscopy, removal of bladder polyps with fulguration, urethral dilation intraoperative findings: severe urethritis with inflammation at anterior wall of urethra, multiple bladder neck polyps.(b)(6) 2017 - in-office cystoscopy - claimant stated voiding is worse when she is constipated, dysuria, bacterial vaginosis with vaginal discharge aris noted to have good support without erosion, tenderness over sling/urethral area with palpation, claimant desires to have aris removed.(b)(6) 2018 - complete removal of aris, anterior repair intraoperative findings: no signs ofextrusion/erosion/compression/bleeding/injury, no obvious source for chronic pelvic pain or irritation from aris/coloplast, very small cystocele discovered/repaired, aris was completely removed up to the level of the entrance into the trans obturator canal.(b)(6) 2018 - past oab symptoms and pelvic pain markedly accelerated after uncomplicated aris/coloplast implant.Symptoms did not improve following aris removal.History of some retention requiring at least intermittent indwelling catheterization prior to sling removal.
 
Manufacturer Narrative
This follow up mdr is created to document the additional patient date of birth, event information, explant date, medical history, and device lot number.Patient code 3191 was selected due to the appropriate codes not available for, nocturia, pressure, inflammatory polyps, oab symptoms.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
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Type of Device
SURGICAL MESH
MDR Report Key9672987
MDR Text Key184826097
Report Number2125050-2020-00117
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Lot NumberAQC60046
Patient Sequence Number1
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