MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX SUPPORT PP TRANSOBTUR KIT X1

Catalog Number URETEXTO

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 01/27/2014

Event Type  Injury  

Event Description

Procedure: gynecology.According to the reporter: the customers reports that the device tears.Another one was used.

Manufacturer Narrative

(b)(4).

• Brand Name: URETEX SUPPORT PP TRANSOBTUR KIT X1
• Type of Device: URETEX SUPPORT
• 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: 3731275
• MDR Text Key: 15175790
• Report Number: 9615742-2014-00118
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041176
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: URETEXTO
• Device Lot Number: SNG0453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other