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

Patient Problems Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Abdominal Distention (2601); 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 incisional ventral hernia.It was reported that after implant, the patient experienced recurrence, open wound, pseudo granuloma, infection, chronic non-healing wound with a small drainage tract from the midline scar, purulent material, infected unincorporated mesh, pain at a firm mass in upper left abdomen, multiple pseudo granulomata, scar tissue, cyclical fevers, chills, erythema, bulge, purulent draining defect in right lower quadrant, and fistula.Post-operative patient treatment included revision surgeries, debridement of cavity, removal of scar tissue, wound exploration, iv antibiotics, repair of hernia with mesh, excision of infected mesh and sutures, excision of draining sinus tract, excision of granuloma, and incision and drainage of wound infection.

• 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: 8927115
• MDR Text Key: 155409979
• Report Number: 1219930-2019-04871
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPM-149
• Device Catalogue Number: SPM-149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• 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
• Patient Age: 59 YR