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

Model Number	SPMM-35
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Emotional Changes (1831); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 a hernia.It was reported that after implant, the patient experienced pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, recurrence, loss of enjoyment of life, inability to participate in usual activities, defective mesh.Post-operative patient treatment included revision surgery, medication, hospitalization, rehabilitation.
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: 14049015
• Report Number: 1219930-2022-01235
• Device Sequence Number: 5872071
• Product Code: FTL
• UDI-Device Identifier: 10884521101425
• UDI-Public: 10884521101425
• 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: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: SPMM-35
• Device Catalogue Number: SPMM-35
• Device Lot Number: 1716063010A1F1053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/07/2022
• 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: Disability; Hospitalization; Required Intervention
• Patient Sex: Unknown