MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE FLAT MESH; SURGICAL MESH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Pain (1994); Injury (2348)

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 this report, a follow-up report will be submitted.

Event Description

The following information was obtained from a literature article titled "laparoscopic sacrocolpopexy (lscp) using an ultra-lightweight polypropylene mesh".At the time of surgery the mean age was 61 (range: 38-85 sd: 10.3), mean bmi was 27 (range: 19-38 sd: 3.9).Total of 156 women in the study.The following adverse events were noted: bladder injury (n=2), ureter injury (n=1), vaginal injury (n=2), rectal injury (n=1), bowel injury (n=2), blood transfusion (n=2).One patient diagnosed with upper posterior vaginal wall extrusion of mesh requiring surgical management.Mesh was palpable during examination in only 3 women, one woman's dyspareunia worsened since her surgery and two participants experienced de novo dyspareunia.Additional complications reported were: anesthetic complications (0.7%), surgical complications (4.6%), return to theatre within 7 days (n=1, 0.7%), uti post-operatively (1.3%, n=2); however these were not included in the published article.

• Brand Name: RESTORELLE FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 8948073
• MDR Text Key: 156090781
• Report Number: 2125050-2019-00698
• 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,literature
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 09/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR