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

Model Number 5195612400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Skin Erosion (2075); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, the patient implanted with this device experienced suprapubic and abdominal pain with sharp pressure when bending over, dysuria, feeling of something poking in her vagina, vaginal pressure when lifting and discomfort for spouse during intercourse due to little pieces of mesh.Doctor performed examination and noted some pain with palpation of device with no erosion visualized or palpated.Patient also experienced mixed urinary incontinence and erosion.A partial excision of the device was performed along with excision of vaginal polyps from prior surgery, urethrolysis, bladder repair, cystocele repair, vaginal mucosa trimming, implant of another manufacturer's device, perineoplasty, and cystoscopy.Intraoperative findings noted a removal of a small piece of blue device, rectocele noted and an intraoperative decision was made to complete a perineoplasty to tighten up the perineal body rather than do an actual rectocele repair, some debris within bladder noted from incomplete bladder emptying likely due to cystocele, and no further device pieces were encountered during the procedure.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14089888
• MDR Text Key: 289516869
• Report Number: 2125050-2022-00379
• Device Sequence Number: 1
• Product Code: OTN
• 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
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5195612400
• Device Catalogue Number: 519561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female