MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE DIRECT FIX POSTERIOR MESH; SURGICAL MESH

Model Number 5012901400

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Scarring (2061); Tissue Damage (2104); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Intermenstrual Bleeding (2665); Constipation (3274)

Event Date 03/14/2012

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device was not explanted or returned.

Event Description

As reported to coloplast though not verified, patient was implanted with restorelle dfp mesh.Later the patient experienced hard stool/constipation, spotting, vaginal/rectal discomfort, shortened vaginal cuff, scarring, recurrent sui, rectocele, dyspareunia, urgency, nocturia, fecal incontinence, incomplete and prolonged voiding, painful defecation, bladder neck mobility, low anal sphincter pressure and rectal/vaginal descent with defecation.Fiber therapy.A cystourethroscopy was performed and was unremarkable for abnormalities.

• Brand Name: RESTORELLE DIRECT FIX POSTERIOR MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west river road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: janell colley ; 1601 west river road north; minneapolis, MN 55411 ; 6122874237
• MDR Report Key: 5095982
• MDR Text Key: 26468167
• Report Number: 2125050-2015-00093
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Report Date: 08/20/2015

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: 5012901400
• Device Lot Number: 10021301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR