MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS® RETROPUBIC SLING SYSTEM; SURGICAL MESH

Model Number 5195622400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scar Tissue (2060); Skin Erosion (2075); Genital Bleeding (4507); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, between (b)(6) 2018-(b)(6) 2019: uti.Urine culture showed 1,000-10,000 cfu/ml enterococcus faecalis and coagulase negative staphylococcus.Blood in urine.Urine culture shows 10,000-50,000 cfu/ml coagulase negative staphylococcus and (b)(6).Urinalysis showed moderate leukocyte esterase, 25-50 wbc and slight bacteria.Urine culture showed >100,000 cfu/ml staphylococcus aureus.Urinalysis showed large leukocytes.Unspecified mechanical complication of genitourinary device, implant and/or graft.Chronic utis, dysuria, sui, urgency, urge incontinence, frequency, nocturia, incomplete bladder emptying, lower pelvic/vaginal pressure, incontinent of stool, mesh erosion-bladder and abdominal wall, pain.On (b)(6) 2018- supris sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, removal of abdominal mesh, removal of mesh from the bladder, repair of bladder from mesh erosion, reinforcement of the bladder and urethral tissues with dermapure via general anesthesia for vaginal pain, bladder pain, abdominal pain, scarring, and mesh erosion.Pathology showed reactive fibrosis, chronic inflammation, and foreign body giant cell reaction surrounding polarizable foreign material, compatible with mesh.Leakage with stress and urge.Urgency, urge incontinence and stress incontinence, dysuria, nocturia, urinary frequency.On (b)(6) 2019-sling urethropexy with unknown mesh, cystocele repair, anterior colporrhaphy, rectocele repair, posterior colporrhaphy, colpoperineorrhaphy, and resection of redundant mons pubis done via general endotracheal anesthesia for sui, cystocele, rectocele, absent perineum, and redundant mons pubis.Light vaginal bleeding, slower urinary stream, difficulty emptying bladder, chills, dysuria.Urine culture done-no results.Uti symptoms.No other adverse patient effects were reported.

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

Correction: item number, udi number.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: SUPRIS® RETROPUBIC SLING SYSTEM
• 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 Key: 13005241
• MDR Text Key: 285924835
• Report Number: 2125050-2021-01774
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932490016
• UDI-Public: 05708932490016
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195622400
• Device Catalogue Number: 519561
• Device Lot Number: 6057014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female