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

Model Number	5013202400
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Flatus (1865); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Burning Sensation (2146); Anxiety (2328); Discomfort (2330); Obstruction/Occlusion (2422); Intermenstrual Bleeding (2665); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Fecal Incontinence (4571); Urinary Incontinence (4572); Swelling/ Edema (4577)
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.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
Event or Problem Description
According to the available information, the patient experienced continued and worsening pain, ptsd symptoms from surgery, difficulty standing for long periods, sutures protruding into rectum, swelling in the vagina, diarrhea with fecal incontinence, uncontrolled flatus, difficulty urinating, and dyspareunia.The mesh was removed during a surgical procedure with cystotomy and vaginotomy.Curled mesh was found during dissection.
Event or Problem Description
Additional information received further reported that between (b)(6) 2015 and (b)(6) 2016 the patient experienced: pelvic pain, back pain, pain and adhesions from the sling and mesh, pain if sitting or standing too long, painful transition from a sitting or standing position.Daily pain limits the patient¿s ability to stand and sit and walk.Severe bulge, dyspareunia, atrophy, chronic pelvic pain, perineal pain with standing, tugging in rectal area.Rectal pain with defecation, difficulty evacuating, rectal pain during bowel movements, vaginal intercourse, or long periods of sitting, tenderness upon palpation of hypertonic puborectalis muscle, intra-anal intussusception, dyssynergia and levator spasm.General consensus the mesh is misplaced and pulling on the rectum.Urethral discomfort with sitting, perineal pain with standing, tugging in the rectal area, vaginal bulge: pain/tugging, dyspareunia: tight introitus, decreased sensation, mesh prominent on digital rectal examination, erosion of mesh into gastrointestinal tract.Mri: scarring from posterior vaginal fornix to rectosigmoid colon.Pelvic pain, dyspareunia, rectal pain, pulling sensation, feeling of a ball in her perineum, labial swelling, difficulty with defecation and urination.Severe pain, mesh causing erosion of the rectal and vaginal mucosa, intense pain in rectal area and urinary hesitancy associated pelvic pain.

• Brand Name: RESTORELLE M
• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12878174
• Report Number: 2125050-2021-01701
• Device Sequence Number: 19234565
• Product Code: OTO
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• Combination Product (Y/N): N
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: Lay User/Patient
• Device Expiration Date: 06/05/2017
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Device Lot Number: 4126804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 12/17/2021
• Date Device Manufactured: 06/06/2014
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female