MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403656

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

Patient Problem Urinary Retention (2119)

Event Date 12/15/2015

Event Type  Injury  

Event Description

It was reported that after a sparc was implanted, the patient experienced retention for 18 hours.After consulting with her surgeon, the patient removed her own foley catheter as she was leaking around it due to bladder spasms.After removing the catheter, the patient voided 4 times with no issues and was no longer incontinent.The patient was thrilled with the results and no further complications were reported related to this device.Related to manufacture report #: 3011770902-2015-00109.

• Brand Name: AMS SPARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5333110
• MDR Text Key: 34638896
• Report Number: 3011770902-2015-00110
• Device Sequence Number: 1
• Product Code: OTN
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2015

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 Expiration Date: 10/02/2018
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 12/29/2015
• Date Device Manufactured: 10/27/2015
• 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): Required Intervention