MAUDE Adverse Event Report: COLOPLAST A/S EXAIR; SURGICAL MESH

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Muscle Spasm(s) (1966); Necrosis (1971); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Myalgia (2238); Urinary Frequency (2275); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Fibrosis (3167); No Information (3190); No Code Available (3191)

Event Date 07/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and no trends were noted.

Event Description

As reported to coloplast though not verified, the patient's legal representative stated on (b)(6) 2013 - (b)(6) 2014 - urinary frequency 12-14x/day, nocturia 2-3x/night, occasional sui, 4 uti's/year with (+) e.Coli with constant dysuria even after treatment, fecal incontinence everyday since (b)(6) 2011, does not wear pads/carries a change of clothes with her at all times, back pain worsens incontinence and urgency, has felt vaginal bulge for 1.5 years when wiping/worse with straining, occasionally has to splint for bowel movement, exair/coloplast palpable anteriorly, tender to palpation, no erosion noted, scar around perineum, possible sphincter involvement, tender to palpation along vaginal cuff scar, mui, fecal incontinence/smearing, myalgia, scar pain, deep dyspareunia, urodynamics - altered sensation.On (b)(6) 2014 - difficult partial removal of anterior exair/coloplast, anal sphincteroplasty, vaginal mucosa trimming, perineoplasty, cystoscopy - intraoperative findings: exair/coloplast tightly banded along anterior vaginal wall with extensive fibrosis between exair/coloplast and the vaginal wall, interior and external anal sphincters with areas of fibrosis pathology: benign squamous mucosa, vaginal mucosa with mild chronic inflammation.On (b)(6) 2014 - approximate 1 cm area of wound breakdown with necrosis at anal sphincteroplasty site, in-office wound culture pathology showed (+) e.Coli.On (b)(6) 2014: anal sphincteroplasty site unchanged.On (b)(6) 2014: anal sphincteroplasty site still approximately 1 cm, now with fresh granulation tissue/healing, blue vicryl suture removed.On (b)(6) 2014: anal sphincteroplasty site healing well, 1 mm area of peritoneum still needing to epithelialize.On (b)(6) 2017: dyspareunia.On (b)(6) 2017: claimant requesting gynecology referral for chronic dyspareunia/pelvic/perineal pain related to exair/coloplast, states urologist is not helping her.This patient also had an aris device, reported under 2125050-2020-00386.

Event Description

Additional information, reported to coloplast though not verified, indicated: (b)(6) 2013 -occasional bladder/bowel incontinence since aris/exair surgeries, fecal urgency, feels like prolapse has recurred, acute low back pain with intermittent right foot numbness, left sciatic pain, feels a knot on left back that is tender, lumbar spine x-ray - normal, lumbar spine ultrasound -normal, unable to do vaginal exam as claimant could not tolerate due to back pain.(b)(6) 2017 - increased dyspareunia, (+) bacterial vaginosis.(b)(6)2017 - vaginal/bladder pressure, deep achiness in lower abdomen/vagina, intermittent sharp/shooting pain through vaginal canal, incomplete bladder emptying, urinary urgency/frequency/dysuria, fee urgency with occasional fecal incontinence, difficulty sleeping, dyspareunia that triggers bladder spasms, interstitial cystitis, fecal incontinence.(b)(6) 2017 - recurrent uti's, continued dyspareunia.(b)(6) 2017 - unable to exercise due to chronic pelvic pain.(b)(6) 2020 - uti with hematuria.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information, reported to coloplast though not verified, indicated (b)(6) 2017: uti (+) staph coagulase.(b)(6) 2017: acute cystitis (+) staph epidermids.(b)(6) 2018: dyspareunia with entry/deep penetration, bilateral inguinal/groin pain, feels "tight", recurrent uti symptoms, urinary frequency, q30mins-1h, urinary urgency, nocturia, dysuria, interstitial cystitis.No aris or exair erosion/exposure noted, chronic pelvic pain, bladder pain.(b)(6) 2020: ed visit: uti with hematuria.

• Brand Name: EXAIR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10222142
• MDR Text Key: 203529728
• Report Number: 2125050-2020-00487
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K112386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Device Lot Number: 2382591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 38 YR