MAUDE Adverse Event Report: UNKNOWN; VAGINAL MESH

UNKNOWN; VAGINAL MESH

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Device Problems Explanted (1217); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/05/2016

Event Type Injury

Event Description

Pt having pain from vaginal mesh.It was surgically removed.

1 Device was Involved in the Event
Brand Name	UNKNOWN
Type of Device	VAGINAL MESH
MDR Report Key	5694917
MDR Text Key	46438888
Report Number	5694917
Device Sequence Number	1
Product Code	FTL
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	05/17/2016
1 Patient was Involved in the Event
Date FDA Received	05/31/2016
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	05/17/2016
Distributor Facility Aware Date	05/05/2016
Device Age	NA
Event Location	Hospital
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 Age	58 YR
Patient Weight	72