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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECT FIX POSTERIOR; SURGICAL MESH
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COLOPLAST A/S RESTORELLE DIRECT FIX POSTERIOR; SURGICAL MESH Back to Search Results
Device Problem Material Erosion (1214)
Patient Problems Abdominal Pain (1685); Erosion (1750); Incontinence (1928); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); Prolapse (2475)
Event Date 02/11/2014
Event Type  Injury  
Event Description
As reported to coloplast though not verified, patient was implanted with coloplast restorelle directfix posterior mesh.Later the patient experienced erosion, exposure, urinary tract infection, dyspareunia, incontinence, blood in stool, recurrent pelvic organ prolapse, abdominal pain, pelvic pain and is unable to participate in intercourse.Bactrim ds prescribed; posterior vagina repair with resection of mesh.Subsequent anterior vaginal repair of cystocele and placement/implant of a competitor's product.After ultrasound, a posterior vaginal wall mesh revision/excision was performed.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).Device not returned.
 
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Brand Name
RESTORELLE DIRECT FIX POSTERIOR
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam-1
humlebaek 3050, dk
Manufacturer (Section G)
COLOPLAST MANUFACTURING US LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
angela killian - head of ra
1601 west river road north
minneapolis, MN 55411
6122874236
MDR Report Key4406455
MDR Text Key5429535
Report Number2125050-2015-00002
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/11/2014
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 Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received01/11/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age39 YR
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