MAUDE Adverse Event Report: COOPERSURGICAL, INC. MILEX PESSARY

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 07/31/2014

Event Type  Other  

Event Description

"pessary was stuck in the pt's vagina.She went to her doctor to have it removed and was unsuccessful.The pt's doctor sent her to the emergency room where they put a hole in the pessary to remove it.".

Manufacturer Narrative

(b)(4).

• Brand Name: MILEX PESSARY
• Type of Device: PESSARY
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: mana banafo ; 95 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4095323
• MDR Text Key: 4762316
• Report Number: 1216677-2014-00013
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/14/2014

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention