MAUDE Adverse Event Report: SOFRADIM PRODUCTION STEX RND THR 12CM X1 MESH, SURGICAL, POLYMERIC

Model Number SYM12F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

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Event Description

Procedure: abdominal wall hernia. According to the reporter: the patient has developed an allergic symptom. Ige levels are high. Eosinophil levels increased. The event occurred/was noticed after the surgery. The surgical time was not extended. There was no tissue damage. The incision site was not extended. Nothing fell into the patient's cavity. No bleeding occurred.

• Brand Name: STEX RND THR 12CM X1
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473
• MDR Report Key: 6169278
• MDR Text Key: 62211993
• Report Number: 9615742-2016-00200
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SYM12F
• Device Catalogue Number: SYM12F
• 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: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown