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

Model Number	SPMM-149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Emotional Changes (1831); Inflammation (1932); Muscle Weakness/Atrophy (1967); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Sepsis (2067); Seroma (2069); Hernia (2240); Discomfort (2330); Ascites (2596); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 (surgipro mesh sublay, product id - spmm149, lot # - a1h0564), & h6 ime e2402: loss of domain, muscle laxity during a detailed review of the received medical records, an additional incident was identified involving a medtronic mesh for the patient reported under regulatory report #9615742-2024-01621.No device allegation were reported by the attorney for this incident.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
During review of medical records received from the patient's attorney, issues were identified after the product was used for therapeutic treatment of a incisional hernia.It was found that after the implant, the patient experienced hernia recurrence, seroma formation, pain, swelling, nausea, diarrhea, adhesions, unusual sensations, fluid collections, discomfort, muscle laxity, nerve irritation, aching, stabbing pain, scarring, weakness of lateral aspect of wound, muscular weakness, nerve damage, inflammation, abscess, cellulitis, sepsis, purulent fluid, necrotic tissue, pain with bending forward, abdominal pain, low mood, loss of domain, & poor muscle quality.Post-operative patient treatment included ct scan, ultrasound, multiple hospitalizations, fluids, analgesia, mesh revision, repair of hernia with sutures, use of drain, adhesions divided, gabapentin, pain medication, scar site injections, paracetamol, anti-inflammatories, primary hernia repair, iv antibiotics, incision & drainage of abscess, necrotic tissue excised, deloculation, curettage, wound packing, wound care, hernia repair with mesh, & use of truss.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20760820
• Report Number: 1219930-2024-05490
• Device Sequence Number: 20972598
• Product Code: FTL
• UDI-Device Identifier: 10884521101401
• UDI-Public: 10884521101401
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: SPMM-149
• Device Catalogue Number: SPMM-149
• Device Lot Number: A1E0048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 05/24/2011
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 101 KG