MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PG RECT 30X15CM; PARIETEX MESH

Catalog Number TEM3015G

Device Problems Material Disintegration (1177); Device Or Device Fragments Location Unknown (2590)

Patient Problems Hernia (2240); Therapeutic Response, Decreased (2271)

Event Date 07/24/2012

Event Type  Injury  

Event Description

Procedure: hernia.According to the reporter: the pt underwent a sublay net augmentation on (b)(6) 2012 with tem3015g inserted.Pt had same indication again and had revision operation on (b)(6) 2014.Several small hernias at media line of abdomen were found, the parietex could not be found in the pt anymore, only some polyester fibers.A new net had to be inserted, size 30 x 20 cm.No blood loss, no tissue loss no part fell into cavity, no extension of incision.Pt had to be re-operated.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX PG RECT 30X15CM
• Type of Device: PARIETEX MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3683042
• MDR Text Key: 4255258
• Report Number: 9615742-2014-00116
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: TEM3015G
• Device Lot Number: SMB00124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other