MAUDE Adverse Event Report: AMS APOGEE; SURGICAL MESH

Model Number REF. 720002-01

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Prolapse (2475)

Event Date 07/17/2014

Event Type  Injury  

Event Description

Had a uterus prolapse.Went in for surgery 2008.Doctor used mesh, apogee system with in.Pro lite.Lot's of problems through out years.No insurance, no doctor.Now after many years of extreme back pain and not being able to control urine it started getting worse.Saw doctor last week and my bladder has now prolapsed.Going to ob doctor friday (b)(6) 2014.Will more than likely have to have mesh removed and repair bladder.

• Brand Name: APOGEE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMS
• MDR Report Key: 3961141
• MDR Text Key: 4556764
• Report Number: MW5037441
• Device Sequence Number: 1
• Product Code: PAJ
• 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: 07/22/2014

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: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: REF. 720002-01
• Device Catalogue Number: REF. 720002-01
• Device Lot Number: 544670013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 52 YR
• Patient Weight: 70