MAUDE Adverse Event Report: COLOPLAST A/S; RESTORELLE DIRECT FIX POSTERIOR

Model Number 5013801400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/17/2011

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

The patient was implanted with coloplast minitape, restorelle a and restorelle p mesh on (b)(6) 2009.Later the patient experienced vaginal bleeding, small exposure and anterior exposure.The mesh was excised and estrogen cream was prescribed on (b)(6) 2010.The patient reported not using the estrogen cream and small pieces of mesh were removed in the office on (b)(6) 2011.

• Type of Device: RESTORELLE DIRECT FIX POSTERIOR
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5208185
• MDR Text Key: 30644878
• Report Number: 2125050-2015-00110
• 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
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5013801400
• Device Catalogue Number: 5013801400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR