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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE - TRANSVAGINAL SURGICAL MESH

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COLOPLAST A/S RESTORELLE - TRANSVAGINAL SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Deformity/ Disfigurement (2360); No Information (3190); 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. (b)(4).
 
Event Description
As reported to coloplast though not verified, the patient's legal representative stated severe pain with daily activities and intercourse and required revision surgery in (b)(6) 2018. Operations to attempt to locate and remove mesh, repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various area of the pelvis, spine and the vagina and operators to remove portions of the female genitalia. Urinary incontinence, physical deformity and the loss of the ability to perform sexually.
 
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Brand NameRESTORELLE - TRANSVAGINAL
Type of DeviceSURGICAL MESH
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
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, mn 
MDR Report Key10098661
MDR Text Key193023003
Report Number2125050-2020-00392
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 other
Type of Report Initial
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
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 Unkown

Patient Treatment Data
Date Received: 05/28/2020 Patient Sequence Number: 1
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