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

Model Number SPM-35

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Injury (2348); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a left inguinal hernia repair with mesh.He had revision surgery 4 years and 10 months post-surgery.The patient experienced surgical revision, pain, infection.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced pain, abscess, infection, colorectal peritoneal fistula, chronic diverticulitis, inflammation, and bulging.Post-operative patient treatment included removal of left groin mesh, sigmoid colon resection with anastomosis, takedown of splenic flexure, wound vac application, and recurrent hernia surgical revision using additional mesh.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced pain and abscess causing infection.Post-operative patient treatment included removal of left groin mesh.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7400150
• MDR Text Key: 104521320
• Report Number: 1219930-2018-01881
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101364
• UDI-Public: 10884521101364
• Combination Product (y/n): N
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: A2L0038X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 84