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

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.

• 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: usauv autumn valentine ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11642071
• MDR Text Key: 244666346
• Report Number: 2125050-2021-00309
• 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: 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 Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Device Lot Number: 2936642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Date Device Manufactured: 09/09/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR