MAUDE Adverse Event Report: COOPERSURGICAL, INC. MILEX PESSARY; INFLATOBALL (100 PERCENT LATEX), MEDIUM

Catalog Number MXKPINFM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See attached investigation.

Event Description

"patient was attempting to remove the pessary when the stem broke.The patient went to the emergency room at the above referenced hospital where it was removed.See attached email response for complete details.Please also reference second complaint (b)(4).".

• Brand Name: MILEX PESSARY
• Type of Device: INFLATOBALL (100 PERCENT LATEX), MEDIUM
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4058906
• MDR Text Key: 52620278
• Report Number: 1216677-2014-00011
• 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: company representative,health
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MXKPINFM
• Device Lot Number: 129084
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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