MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH

Catalog Number 720088-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Retention (2119); Distress (2329)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of an advance sling in 2012, the patient initially regained continence but "later presented again with incontinence".The sling was removed as it "had eroded into the bladder neck"."the doctor did say that if he develops structure from where the defect was in the urethra, he may need a uretheroplasty, but he did not think that would be the case".No further patient complications were reported in relation with this event.

Event Description

Additional information reported by the patient: "on (b)(6) 2012, dr.Used a different technique making one long incision between my testes and anus.When i started having complications not be able to urinate for approximately 12 weeks using a catheter, a stream here and there.He say i might have tightened it too much, i may have to go back in.Around (b)(6), i became full incontinence".Patient indicates "for 3 years(1) i have been in pain and tenderness on each testis up to the shaft of the penis.(2) weak urine stream with pain and an achy sensation.(3) before surgery i was using two pads or less to outer catheter full incontinence, the only relief is sitting or lying down.(4) uncomfortable sitting at times, bending over touching my toes there is pain-stiffness in the groin area also squatting." no further patient complications were reported in relation with this event.

Manufacturer Narrative

Implant date: 2012.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4454479
• MDR Text Key: 5421654
• Report Number: 2183959-2015-00048
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: Lay User/Patient
• Device Catalogue Number: 720088-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR