MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES -3004086170 PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE

Catalog Number 482151

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

Patient Problems Unspecified Infection (1930); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2016 bimonthly asr.(b)(4).The total number of events for product classification code is (b)(4).Qty 5 - pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 7 - pelvilace to biourethral support system needle and implant hook needle 50cm.(b)(4).Sample not returned.

Event Description

(b)(6) 2016 bimonthly asr.

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5650966
• MDR Text Key: 45049337
• Report Number: 1018233-2016-00619
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

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: No Information
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 482151
• Device Lot Number: CVTA0001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 05/12/2016
• 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): Required Intervention