MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE - UNKNOWN; SURGICAL MESH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 Description

According to the available information, the patient had laparoscopic sacrocolpopexy for recurrent vaginal prolapse and a non-coloplast tvt for stress incontinence in 2016.The patient had left sided pelvic pain and pain on intercourse.Examination under anaesthesia + cystoscopy were performed to investigate the pain.The findings were 3 cms mesh extrusion into vagina, no mesh extrusion of tvt noted, and cystoscopic examination- normal.The patient was made aware and was referred to tertiary centre.

Manufacturer Narrative

This follow-up mdr is created to document the patient sex and conclusion of the investigation.No components were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of extrusion quality accepts the physician's observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• Brand Name: RESTORELLE - UNKNOWN
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west river road north; minneapolis, mn
• MDR Report Key: 9800210
• MDR Text Key: 183341333
• Report Number: 2125050-2020-00205
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other