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

Model Number	5015202400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Incompetent Cervix (1927); Fecal Incontinence (4571)
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.Device not returned.
Event or Problem Description
According to available information, the physician reported a tear in a restorelle y contour.Mesh tore, bad cervix came out.Fecal incontinence also occurred.The physician did a re-do by buttressing upsylon to mesh that remained.

• Brand Name: RESTORELLE Y CONTOUR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12285441
• Report Number: 2125050-2021-01089
• Device Sequence Number: 14255582
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1
• Patient Age: 66 YR