• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR SURGICAL MESH Back to Search Results
Model Number 5014602400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123); Prolapse (2475); Genital Bleeding (4507)
Event Type  Injury  
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa. Devices met specification prior to release and no trends were noted. 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
As reported to coloplast, though not verified, the patient experience pain, vaginal discharge and bleeding, mesh erosion, recurrent rectocele, vaginal vault prolapse, and cystocele. Excision of the eroded/expose mesh was performed, and the posterior vaginal wall was reconstructed utilizing another manufacturer¿s product. An unknown pelvic organ prolapse mesh was used for robotic-assisted laparoscopic sacrocolpopecy. Intraoperatively, significant mesh erosion was observed in the left posterior vaginal wall with approximately two centimeters of exposure. It was noted the mesh incorporated into fibromuscular tissue beneath the epithelium.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTORELLE DIRECTFIX POSTERIOR
Type of DeviceSURGICAL 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
usauv autumn valentine
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11642071
MDR Text Key244666346
Report Number2125050-2021-00309
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2014
Device Model Number5014602400
Device Catalogue Number501460
Device Lot Number2936642
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/09/2021 Patient Sequence Number: 1
-
-