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

Model Number UNKNOWN PARIETEX

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Hernia (2240); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Model #/lot #: since the lot number was not provided, this information cannot be determined.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

According to the reporter: the patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Approximately 3 years post op the hernia recurred.Approximately 4 years post op a doctor repaired the recurrent hernia and removed part of the mesh that had been placed in the first surgery.Following the hernia repair surgery the patient suffered tachycardia, hypotension, and difficulty breathing.As a result he was transferred to icu.Treatment received by the patient included cardioversion and cardiac pacemaker.Because of the cardiac complications the patient suffered from the repair surgery the patient remained in the hospital longer than expected.Following the repair surgery the doctor told the patient that the mesh placed in the first surgery has been placed wrong.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The preoperative and postoperative diagnosis was incision hernia.The procedure performed was a laparoscopic incisional hernia repair.

Manufacturer Narrative

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

Event Description

Per additional information received, the existing mesh had migrated to mostly to the left side of the abdominal wall.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PARIETEX
• 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6798851
• MDR Text Key: 82842568
• Report Number: 9615742-2017-05203
• 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: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention