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

Model Number SPM-149

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Injury (2348); Impaired Healing (2378); Ascites (2596); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced abscess, infection, open wound, mesh had bunched down and withdrawn nearly 7 cm from where it had been anchored, phlegmon surrounding mesh and intraabdominal fluid, abdominal pain, fever, murky fluid, large purulent phlegmon, and mesh had bunched down around the phlegmon and withdrawn from where it had been previously anchored.Post-operative patient treatment included aspiration of subfascial abscess, wound left open with packing, complex open abdominal wound closure, explantation of infected mesh as well as incision and drainage of intraabdominal fluid consistent with abscess.

• 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: 8987470
• MDR Text Key: 157289943
• Report Number: 1219930-2019-05134
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101333
• UDI-Public: 10884521101333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: SPM-149
• Device Catalogue Number: SPM-149
• Device Lot Number: A1C0052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Date Device Manufactured: 04/29/2011
• 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