MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC COLOPLAST RESTORELLE Y CONTOUR MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

Model Number 501520

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Product is coloplast restorelle y contour mesh, model #501520, lot #6955695.Implant (b)(4); implanted (b)(6) 2020 at time of hysterectomy to treat uterovaginal prolapse.Prolapse recurred, taken back to surgery (b)(6) 2021 for revision.The 'y' arm of the implant (between the 'v' and the terminal end of the implant) had broken in half (i.E.Mesh was intact on the vagina and intact on the sacrum, but had fracture in two in between, resulting in recurrent prolapse).This was repaired by tacking a new piece of mesh to the vaginal arm and tacking the new piece of mesh back to the sacrum.Fda safety report id # (b)(4).

• Brand Name: COLOPLAST RESTORELLE Y CONTOUR MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 12771284
• MDR Text Key: 280581328
• Report Number: MW5105163
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 501520
• Device Catalogue Number: 501520
• Device Lot Number: 6955695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White