MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number SPMM-149

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Prolapse (2475); No Code Available (3191)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operative a laparoscopic hysteropexy/ y/ mesh placement for pelvic organ prolapse, the mesh eroded.The patient attended with pain and recurrence of pelvic organ prolapse.The patient requested to remove the mesh.Laparoscopic assisted removal of mesh and subsequent vaginal hysterectomy and anterior colporrhaphy was done to resolve the issue.An unanticipated tissue loss and tissue damage resulted from this problem.The surgical procedure was extended for more than 30 minutes.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8042240
• MDR Text Key: 126260475
• Report Number: 1219930-2018-05875
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101401
• UDI-Public: 10884521101401
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2014
• Device Model Number: SPMM-149
• Device Catalogue Number: SPMM-149
• Device Lot Number: A5H0642WX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/06/2018
• Date Device Manufactured: 08/15/2015
• 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): Life Threatening; Required Intervention