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

Catalog Number 72403656

Device Problem Contamination (1120)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/17/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of a sparc, the patient experienced a lower urinary tract infection (uti).It was also reported that the patient called with complaint of symptoms of a uti.The patient had a urine specimen submitted to quest lab and was prescribed macrobid 100mg, by mouth, twice a day on (b)(6) 2015.On (b)(6) 2015 the patient was found to be ecoli resistant to macrobid which was then switched to keflex 500mg, by mouth, twice daily for 7 days.The patient then had complaint of symptoms of a uti the week of (b)(6) 2016.The patient then had her urine collected, again, on (b)(6) 2016.The event was considered resolved/recovered with no sequelae on 01/12/2016.If additional information is received, a follow up report will be sent.

• 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: 5443933
• MDR Text Key: 38443163
• Report Number: 3011770902-2016-00066
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

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: 09/02/2018
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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
• Treatment: NATIVE TISSUE CYSTOCELE REPAIR
• Patient Outcome(s): Required Intervention