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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 5607819-038
Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Burning Sensation (2146); Discharge (2225); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Blood Loss (2597); 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 oto asr exemption # e2014015 for february-march 2017.This mdr is to reflect the additional information to be added to the initial asr report.(b)(4).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 oto asr exemption # e2014015 for february-march 2017.This mdr is to reflect the additional information to be added to the initial asr report.Additional information reported to coloplast though not verified, indicated discomfort, burning/pain, neuralgia, bloody discharge, granulation tissue at the left vaginal cuff and atrophic/inflamed vaginal mucosa, mild urinary frequency, mesh erosion.On (b)(6) 2015 - excision of vaginal mesh, revision of vaginal cuff an cystourethroscopy.On (b)(6) 2015 - multiple uti's with hematuria.On (b)(6) 2019 - bothersome recurrent mesh erosion.On (b)(6) 2019 - excision of vaginal mesh and cystourethroscopy.
 
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Type of Device
SURGICAL MESH
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, mn 
MDR Report Key10343114
MDR Text Key206818936
Report Number2125050-2020-00539
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
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Device Operator No Information
Device Lot Number5607819-038
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/30/2020
Type of Device Usage N
Patient Sequence Number1
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