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

Model Number 5014602400

Device Problem Missing Information (4053)

Patient Problem Incontinence (1928)

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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, reported complaint, abstract article: this single-center study included 40 patients who underwent transvaginal mesh hysteropexy.Complications: 1 patient required a blood transfusion for symptomatic anemia (clavien-dindo grade ii).One patient received a transfusion of packed red blood cells due to an estimated blood loss of 700 ml.One patient reported de novo dyspareunia due to introital tightness following concomitant perineoplasty.One patient required a perineal relaxing incision in office under local anesthesia.Two patients reported de novo urgency incontinence, but no treatment was required.In conclusion, this study highlights the fact that the uterus can be retained with minimal surgical complications and high composite success.We look forward to following these subjects to determine longer-term safety of using synthetic mesh for hysteropexy.

• Brand Name: RESTORELLE DIRECTFIX POSTERIOR
• Type of Device: 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: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10995752
• MDR Text Key: 221246493
• Report Number: 2125050-2020-01269
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1