MAUDE Adverse Event Report: VAGINAL GRAFT

VAGINAL GRAFT

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/14/2014

Event Type Injury

Event Description

Previous sacrospinous ligament fixation and posterior vaginal graft placement.She experienced dyspareunia and desired surgical excision.

1 Device was Involved in the Event
Brand Name	VAGINAL GRAFT
Type of Device	VAGINAL GRAFT
MDR Report Key	3647118
MDR Text Key	19769641
Report Number	MW5034690
Device Sequence Number	1
Product Code	PAJ
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Voluntary
Reporter Occupation	Other
Type of Report	Initial
Report Date	02/20/2014
1 Patient was Involved in the Event
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	Other
Is the Reporter a Health Professional?	Yes
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	02/21/2014
Patient Sequence Number	1
Patient Outcome(s)	Hospitalization;
Patient Age	67 YR
Patient Weight	60