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

Model Number PCO6VP

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operatively the mesh was torn.The mesh was implanted during an umbilical hernia repair, while doing an open repair operative approach and after insertion into the patient, the mesh was wet after soaking water.The mesh is soaked in saline after opening before being implanted.There were 4 fixation points used for the suture in the wound closure.The doctor suspected that one of the flaps on the mesh was damaged by accident after the patient was discharged.The patient has no injury.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED 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: sharon muprhy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7083812
• MDR Text Key: 93766788
• Report Number: 9615742-2017-05878
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PRA1794X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2017
• Date Device Manufactured: 01/02/2017
• 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