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

Model Number	SPM-35-W
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced defective mesh, failure of mesh, scarring, disfigurement, mental pain, pain, adhesions, erosion, wound dehiscence, infection, abscess, mesh not incorporated, permanent physical deformity, recurrence, and abdominal pain.Post-operative patient treatment included drainage of abscess, removal of mesh, and hernia repair with new mesh.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• Common Device Name: 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14168609
• Report Number: 1219930-2022-01433
• Device Sequence Number: 12197956
• Product Code: FTL
• UDI-Device Identifier: 10884521101371
• UDI-Public: 10884521101371
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K915526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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-35-W
• Device Catalogue Number: SPM-35-W
• Device Lot Number: A5K304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Unknown