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

Model Number UNKNOWN SURGIPRO MESH

Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Anxiety (2328); Distress (2329); Depression (2361); Impaired Healing (2378); Hematuria (2558); Fluid Discharge (2686); Thrombosis/Thrombus (4440); Sexual Dysfunction (4510); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 a laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, infection, mesh erosion, hematuria, fistula, abscess, mesh migration, damage to the bladder, and pain and suffering.Post-operative patient treatment included mesh removal surgery, and revision surgery.

Manufacturer Narrative

Additional information: b5, d3(mfr name, street 1, mfr region, country code, postal code), d6b, g3, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 a laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced inflammation, bacterial infection, mesh degradation, mesh not properly incorporated in tissue, chronic draining abscess, bladder lesion, mesh extrusion, draining wound, large bladder stone, nausea, loss of appetite, stress/anxiety, defective device, mental and physical pain, injury, disability, loss of enjoyment of life, recurrence, adhesions, infection, mesh erosion, hematuria, fistula, abscess, mesh migration, damage to the bladder, and pain and suffering.Post-operative patient treatment included mesh removal surgery, hernia repair, lysis of adhesions, cystoscopy, placement of new mesh, drainage of abscess, and revision surgery.

Manufacturer Narrative

Additional info: a4, b5, b7, d6b, h6 (patient codes, imf code, ime e2402: "loss of appetite, bladder lesions, large bladder stone, t hickened bladder wall").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 Description

The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced bleeding, blood with ejaculation, bladder defect, blood clots, thickened bladder wall, abdominal pain, poor sex life, blood in urine and sperm, depression, inflammation, bacterial infection, mesh degradation, mesh not properly incorporated in tissue, chronic draining abscess, bladder lesion, mesh extrusion, draining wound, large bladder stone, nausea, loss of appetite, stress/anxiety, defective device, mental and physical pain, injury, disability, loss of enjoyment of life, recurrence, adhesions, infection, mesh erosion, hematuria, fistula, abscess, mesh migration, damage to the bladder, and pain and suffering.Post-operative patient treatment included mesh removal surgery, hernia repair, lysis of adhesions, cystoscopy, placement of new mesh, drainage of abscess, and revision surgery.

• 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: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 12112123
• MDR Text Key: 260214645
• Report Number: 9615742-2021-01651
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 06/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGIPRO MESH
• Device Catalogue Number: UNKNOWN SURGIPRO MESH
• Device Lot Number: AOB254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 06/19/2024
• Supplement Dates FDA Received: 11/15/2021; 06/25/2024
• 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; Disability
• Patient Sex: Male
• Patient Weight: 78 KG