MAUDE Adverse Event Report: COLOPLAST A/S STORELLE DIRECTFIX ANTERIOR; SURGICAL MESH

Model Number 5014502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144); Dysuria (2684)

Event Date 01/07/2017

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, restorelle 522 - difficulty emptying bladder.Nausea, vomiting and feeling of not emptying bladder that same day (b)(6) 2017.Subject was hospitalized and is being treated with levaquin 500 mg iv daily.Diagnosed with right pyelonephritis.Subject treated with zolfran 4 morphine 4 levaquin 750 0.4 tylenol 325.Subject discharged from hospital on (b)(6) 2017.

• Brand Name: STORELLE DIRECTFIX ANTERIOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 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: 6290581
• MDR Text Key: 66191014
• Report Number: 2125050-2017-00005
• 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,study
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5014502400
• Device Catalogue Number: 5014502400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 01/31/2017
• 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