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

Model Number	5208102400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Perforation (2001); Scar Tissue (2060); Distress (2329); Depression (2361); Neuralgia (4413); Paresthesia (4421); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Sexual Dysfunction (4510); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the legal representative stated sustained permanent pain, perforation, disability, impairment of mobility, impairment of sexual function, impairment of bowel and bladder function, chronic inflammation, chronic foreign body reaction, entrapment, aggravation, irritation and/or compression of her obturator, pudendal and/or ilioinguinal nerve which in turn damaged and aggravated the surrounding soft tissues.As a result, the patient also experienced paresthesia, depression, and emotional distress.The patient experienced erosion, dyspareunia, neuromuscular pain, pudendal neuralgia, disabling pelvic pain, abdominal pain, groin pain, recurrence of incontinence, oration, vaginal scarring and has undergone medical treatment.
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
Additional information received on 10/31/2022 provided the following: (b)(6) 2019 vaginal pain, difficulty with defecation.(b)(6) 2021 pudendal neuralgia, worsening pain.(b)(6) 2020 pelvic pain, dyspareunia; bacterial vaginosis.(b)(6) 2021 mesh erosion noted at the site of the sling and midurethra (obtryx sling) dehiscence of the vaginal cuff with mesh 3-4 cm open from the vaginal cuff (restorelle y).(b)(6)2021 large mesh erosion noted from vaginal cuff with dehiscence, 6cm vaginal cuff pelvic pain, difficulty voiding, dyspareunia.(b)(6) 2021 vaginal cuff tenderness radiated near the clitoral area.(b)(6) 2021 levator muscle spasm ¿ pudendal nerve block.
Additional Manufacturer Narrative
Lot number: 1392084 - the lot number was reviewed for complaint trend, nonconforming report and capa.

• Brand Name: RESTORELLE Y
• 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: 15418837
• Report Number: 2125050-2022-00919
• Device Sequence Number: 17780673
• Product Code: OTO
• UDI-Device Identifier: 05708932553773
• UDI-Public: 05708932553773
• Combination Product (Y/N): N
• PMA/510(K) Number: K112322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 11/16/2022

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 Model Number: 5208102400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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 Sex: Unknown