MAUDE Adverse Event Report: INTEGRA YORK, PA INC PESSARY FITTING SET OF 6 SIZES; M7-OB-GYN

Catalog Number 30-FS1000

Device Problem Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Discomfort (2330); Reaction (2414)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

The pt reported that the doctor inserted two pessaries (from the fitting set) and they were not in for more than 30 seconds.Everything seemed fine and then 4-5 hours later that evening the pt started to have some vaginal burning and trouble having a bowel movement.Pt reports she has never had a problem with latex gloves so she thought maybe this was due to a silicon allergy.On (b)(6) 2014, pt reports that for sizing purposes a #4 pessary was inserted/removed and a #5 pessary was inserted/removed.Pt is allergic to lubricants so devices were inserted using water.Doctor does not believe she was reacting to the device but could not rule it out.On (b)(6) 2014, doctor reports event occurred (b)(6) 2014.Pt was reexamined (b)(6) 2014 and still had some discomfort.Doctor found no inflammation or drainage in vaginal canal.Pt was referred to an allergist.Pt has not been heard from since (b)(6) 2014.

Manufacturer Narrative

The device involved in the reported incident is not available for eval.An investigation has been initiated based on the reported info.

• Brand Name: PESSARY FITTING SET OF 6 SIZES
• Type of Device: M7-OB-GYN
• Manufacturer (Section D): INTEGRA YORK, PA INC; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 3802651
• MDR Text Key: 20787915
• Report Number: 2523190-2014-00011
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30-FS1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR