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

Model Number PCO1510X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fever (1858); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant product: unknown absorbatack (lot# unknown). 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 incisional epigastric hernia. It was reported that after the implant, the patient experienced distended small bowel, adhesions, hernia recurrence, seroma, infection, hematoma, mesh erosion into viscera, abscess, pain, swelling, drainage, discomfort, fluid collection, blood loss, cloudy fluid, fever, fibrous and adipose tissue, vascular congestions, inflammation, foreign body giant cell reaction, granulation tissue changes, multinucleated giant cells, and open wound. Post-operative patient treatment included small bowel resection, lysis of adhesions, hernia repair with new mesh, drainage of seroma, exploration of surgical wound and abdominal wall, debridement, revision surgery, mesh removal, feeding jejunostomy, fluid aspirated, antibiotics, capsule dissected and excised down to mesh, evacuation of hematoma, wound packed, wound irrigated, and wound vac.

• Brand Name: 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12326211
• MDR Text Key: 266718416
• Report Number: 9615742-2021-01993
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 01/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2013
• Device Model Number: PCO1510X
• Device Catalogue Number: PCO1510X
• Device Lot Number: PLJ00198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• 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: 08/16/2021 Patient Sequence Number: 1