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

Catalog Number URETEXSUP

Device Problem Insufficient Information (3190)

Patient Problems No Information (3190); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Procedure: urogynecological.According to the reporter: it is noted that the litigation received (b)(6) 2014 alleges a deficiency against the uretex to trans-obturator urethral support system; however, the implant sheet received the same day shows the product implanted to be uretex sup urethral support system; therefore, an additional complaint (this complaint) was opened for uretex sup.

Manufacturer Narrative

(b)(4).Covidien is submitting this report on behalf of (b)(4).

Manufacturer Narrative

Tracking number: (b)(4).Exemption number: 2013003.Bard' s tracking number: (b)(4).

Event Description

Per additional information received, the patient has experienced irritative bladder symptoms, bladder calculi, foreign body in the bladder, mesh material inside the stone necessitating electrohydraulic lithotripsy and removal of foreign body in bladder.

• Brand Name: URETEX SUPPORT PP KIT X1
• Type of Device: URETEX SUPPORT
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3600541
• MDR Text Key: 4088214
• Report Number: 9615742-2014-00018
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

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 Catalogue Number: URETEXSUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female