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

Model Number PCO2015

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Neovascularization (1978); Pain (1994); Hernia (2240); Ascites (2596); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: bard- 38 cm sorbafix absorbable fixation system- product id: 0113080, lot #: dath0003, exp. Date 2010-08, abstack20 abstack20 5 mm sgl use abs dev 20 tacks lot number: n9c0904. (b)(4). 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 laparoscopic therapeutic treatment of a spigelian ventral hernia. It was reported that after the implant, the patient experienced recurrence, adhesions, mesh migration, edema, neovascularization, wound through the middle of the mesh at the hernia site, omentum of the transverse colon found adhered loosely to the mid anterior abdominal wall, bulging, pain, leukocytosis, left ovarian cyst, and peritoneal fluid in abdominal cavity. Post-operative patient treatment included hernia repair with new mesh, takedown of adhesions, diagnostic laparoscopy, and removal of mesh.

• 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 80301 ; 3035816943
• MDR Report Key: 12025310
• MDR Text Key: 260218633
• Report Number: 9615742-2021-01468
• 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: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2013
• Device Model Number: PCO2015
• Device Catalogue Number: PCO2015
• Device Lot Number: PIG00694
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/02/2021
• 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: 06/18/2021 Patient Sequence Number: 1