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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST CORP (MPO)RESTORELLE DIRECTFIX ANT SURGICAL MESH

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COLOPLAST CORP (MPO)RESTORELLE DIRECTFIX ANT SURGICAL MESH Back to Search Results
Model Number 5014502400
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Numbness (2415); Prolapse (2475); Hematuria (2558); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

As reported to coloplast though not verified, patient's legal representative stated foreign body reaction, pain, urinary problems, urinary retention, pressure, pain, inflammation, painful urination, numbness, dyspareunia, difficulty voiding, difficulty emptying bladder, burning sensation, infections and other injuries.

 
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Brand Name(MPO)RESTORELLE DIRECTFIX ANT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST CORP
1601 west rivier road north
minneapolis MN 55411
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis, mn, MN 55411
6123578517
MDR Report Key8651131
MDR Text Key146403680
Report Number2125050-2019-00421
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup,Followup,Followup
Report Date 07/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5014502400
Device Catalogue Number501450
Device LOT Number5361821
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/29/2019 Patient Sequence Number: 1
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