MAUDE Adverse Event Report: AMERICAN MEDICAL MALE SLING WITH INVANCE DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Discharge (2225)

Event Date 04/02/2015

Event Type  Injury  

Event Description

Had an ams sling placed in (b)(6) 2009.Then noticed localized abscess in late 2014.Had a fistula discharging from my perineum in early 2015.Had outpatient exploratory surgery to remove the fistula and, as it turns out, remove the sling as it was the cause of the infection done on (b)(6) 2015 with an overnight stay in the hospital.

• Brand Name: MALE SLING WITH INVANCE DEVICE
• Type of Device: MALE SLING WITH INVANCE DEVICE
• Manufacturer (Section D): AMERICAN MEDICAL
• MDR Report Key: 4764497
• MDR Text Key: 5789311
• Report Number: MW5042596
• Device Sequence Number: 1
• Product Code: OTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2015
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; RX MEDS: METROPOLOL; LIPITOR; OTC MEDS: ASPIRIN; MULTIVITAMIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 84