MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR; SURGICAL MESH

Model Number	5014502400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Prolapse (2475); Abdominal Cramps (2543); Kidney Infection (4502); Dyspareunia (4505); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced dyspareunia, severe pelvic pain, urinary urgency problems and difficulty with daily activities.Two surgeries were performed to remove the device.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.¿ there were no nonconforming reports nor capas identified against this lot number.Devices met specification prior to release.
Event or Problem Description
Additional information received on 1/29/2023 as follows: the restorelle directfix was implanted on 9/2/2015.Beginning (b)(6) 2015 extending through (b)(6) 2019 the patient at some time experienced the following symptoms, occasional pink discharge, cramping, vaginal discharge/bleeding.A physical exam found a 3x4 mm mesh exposure of anterior vaginal wall and a second area of exposure 1x3 mm midline, 2cm from cuff.Recurrent urinary tract infections and grade 1 rectocele were observed.An mri of the pelvis suggests erosion along the mesh arm.On (b)(6) 2018 vaginal mesh excision of the restorelle directfix was performed.Bladder neck polyps were noted under general anesthesia with evidence of mesh in the bladder and transvaginal mesh exposure was observed along with acute and chronic inflammation and a foreign body reaction to refractile material and adherent mesh.Additional symptoms observed were purulent discharge and possible mesh infection with tracking of the infection along the mesh arm to the perineal body.Ct of the pelvis revealed complex fluid collection in the pelvis, concerning for abscess.Pelvic abscess found on ct treated with medication.Transvaginal removal of additional infected mesh (restorelle), with vaginoscopy confirming more mesh deep in the pelvic side wall, additional mesh removal including ethibond suture holding mesh in place deep on the right side.Cystoscopy and vaginoscopy are negative.Bladder wall appeared moderately trabeculated.The patient is referred to pelvic rehab.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Common Device Name: 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: 12528155
• Report Number: 2125050-2021-01363
• Device Sequence Number: 4291045
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (Y/N): N
• PMA/510(K) Number: K103568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 3812401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 01/29/2023
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 02/02/2023
• Date Device Manufactured: 09/25/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female