MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO2520

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Pain (1994); Renal Failure (2041); Seroma (2069); Hernia (2240); Distress (2329); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); 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 therapeutic treatment of a hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, and dense adhesions. Treatment required included surgical revision of the mesh.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, leukocytosis, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and dense adhesions. Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.

Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

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 an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound with hematoma, and dense adhesions. Treatment required included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, and wound/hematoma evacuation.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, recurrence of hernia, infection of a cavity beneath the mesh filled with clot/pus, abscess, open wound, hematoma, fluid collections, gi distress, pain, nausea, fevers, hypotensions, decreased hematocrit, altered mental status, seroma, distention, renal failure, postop ileus, and dense adhesions. Post-operative patient treatment included surgical revision, adhesiolysis, explant of the mesh, implant of new mesh, transfusion of 4 units packed red blood cells, iv antibiotics, oxygen, diuresis, ng tube for drainage, pain medications, iv fluids, advair, aspiration of seroma, drain placed, and wound/hematoma evacuation.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (b)(4). If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 7997615
• MDR Text Key: 124788309
• Report Number: 9615742-2018-02399
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2004
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: D22343PCO25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/23/2018 Patient Sequence Number: 1