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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE - UNKNOWN SURGICAL MESH Back to Search Results
Model Number 5014401400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Neuropathy (1983); Urinary Tract Infection (2120); Burning Sensation (2146); Prolapse (2475); Dyspareunia (4505); Increased Sensitivity (4538); Fecal Incontinence (4571); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This event was previously submitted under manufacturer report number 2125050-2020-00322; this report is being submitted to report additional information received regarding the events in 2125050-2020-00322. 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 inter alia, severe pain with daily activities and intercourse, severe emotional pain and injury, increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries. Underwent operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine and the vagina, and operations to remove portions of the female genitalia. Urinary incontinence, physical deformity and the loss of the ability to perform sexually. It was noted that the plaintiff required surgical revision of the mesh in (b)(6) 2019, and again in (b)(6) 2019. Additional information received reported on 11feb2019 the patient was experiencing dyspareunia, there were signs of nerve damage & stunting from restorelle. The surgical revision in (b)(6) 2019 involved excision/revision of anterior and posterior, excision of vaginal wall. Chronic inflammation was also noted. The intervention in (b)(6) 2019 included partial excision. Additional information received further reported that between (b)(6) 2018 and (b)(6) 2018, the patient experienced stabbing suprapubic pain with sitting, squatting, and leaning over, constant dull pain inside the vagina, pelvic pain, dyspareunia, feels her vagina is too short now, difficulty with penetration due to partner¿s large size, tender to palpitation over r>l levators, right obturator, and anterior vaginal wall.
 
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Brand NameRESTORELLE - UNKNOWN
Type of DeviceSURGICAL 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 Key11518487
MDR Text Key240793079
Report Number2125050-2021-00223
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014401400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/18/2021 Patient Sequence Number: 1
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