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

Model Number	SPM-149
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
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
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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8927115
• Report Number: 1219930-2019-04871
• Device Sequence Number: 2206985
• Product Code: FTL
• UDI-Device Identifier: 10884521101333
• UDI-Public: 10884521101333
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K915526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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 Model Number: SPM-149
• Device Catalogue Number: SPM-149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/23/2019
• 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: Required Intervention
• Patient Age: 59 YR