MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB; MESH, SURGICAL, POLYMERIC

Model Number TINTRAS

Device Problem Off-Label Use (1494)

Patient Problems Unspecified Infection (1930); Neonatal Deformities (1974); Seroma (2069)

Event Date 06/01/2011

Event Type  Injury  

Manufacturer Narrative

This event is being reported as part of a remediation project.

Event Description

It was reported that a mesh has been used for gastroschisis treatment.The neonate patient had a post infection after mesh implantation.10-12 days after implantation, and after discontinue of antibiotics, patient had fever and infection because seroma passed through mesh and came under skin because the patient had a thin skin layer, infection occurred.The mesh was removed.

• Brand Name: SURGIMESH XB
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL; la talaudiere ; FR
• Manufacturer Contact: david houot ; 246 allee lavoisier; la talaudiere 42350 ; FR 42350 ; 77531659
• MDR Report Key: 5006908
• MDR Text Key: 23256028
• Report Number: 3006617478-2015-00011
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K072974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 07/04/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: TINTRAS
• Device Lot Number: F03055A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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): Hospitalization
• Patient Age: 2-3