MAUDE Adverse Event Report:; MESH URETHRAL SLING

; MESH URETHRAL SLING

Device Problems Explanted (1217); Device Issue (2379)

Patient Problem Incontinence (1928)

Event Type Injury

Event Description

Patient had mesh mid urethral sling removal and replacement.The patient states she has had problems with the device since having a hysterectomy.

1 Device was Involved in the Event
Brand Name	UNK
Type of Device	MESH URETHRAL SLING
MDR Report Key	6393178
MDR Text Key	69640093
Report Number	6393178
Device Sequence Number	1
Product Code	OTN
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	03/02/2017
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	Yes
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	03/02/2017
Distributor Facility Aware Date	02/28/2017
Device Age	6 YR
Event Location	Hospital
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	03/02/2017
Was Device Evaluated by Manufacturer?	No Information
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Hospitalization;
Patient Weight	77