MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number LPG1510

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

Patient Problems Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Seroma (2069); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Weight Changes (2607); Constipation (3274); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced defective device, swelling, pain, constipation, decreased appetite, weight loss, recurrence, seroma, mesh pushed to one side, discomfort, mesh migration, mental pain, scarring, permanent impairment, and loss of enjoyment of life.Post-operative patient treatment included primary hernia repair, removal of mesh, revision surgery, and dissection of seroma.

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 therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced defective device, swelling, pain, constipation, decreased appetite, weight loss, recurrence, seroma, mesh pushed to one side, discomfort, mesh migration, mental pain, scarring, permanent impairment, fibroadipose tissue, burning sensation, and loss of enjoyment of life.Post-operative patient treatment included primary hernia repair, removal of mesh, revision surgery, medication, and dissection of seroma.

Manufacturer Narrative

Additional information: a3, a3, a4, b5, b7, h6 (added patient and imf codes, ime 2402: fibroadipose tissue, weight loss) 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.

• Brand Name: PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16128103
• MDR Text Key: 306975852
• Report Number: 9615742-2023-00052
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513136
• UDI-Public: 10884521513136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120897
• 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
• Report Date: 08/19/2024

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 Expiration Date: 02/28/2023
• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Device Lot Number: PUC1173X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 08/14/2024
• Supplement Dates FDA Received: 08/22/2024
• Date Device Manufactured: 03/26/2020
• 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: Female
• Patient Weight: 107 KG