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

Model Number	SPMM-149
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Prolapse (2475); No Code Available (3191)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8042240
• Report Number: 1219930-2018-05875
• Device Sequence Number: 13819160
• Product Code: FTL
• UDI-Device Identifier: 10884521101401
• UDI-Public: 10884521101401
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K915526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention