MAUDE Adverse Event Report: COOPERSURGICAL, INC. KIT-RING W/SUPP.#4 70MM; PESSARY KIT-RING W/SUPP.#4 70MM

Model Number MXKPRS04

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the device is received by coopersurgical inc.The investigation will be completed and a follow-up report will be filed.Ref e-complaint: (b)(4).

Event Description

"flash from the mold process that made me bleed".Ref e-complaint: (b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the device is received by coopersurgical inc.The investigation will be completed and a follow-up report will be filed.(b)(4).On 2/2/2016 *investigation: initiated manufacturer's investigation.No sample returned.Review dhr.Inspect returned samples.Inspect stock product.*analysis and findings: it has been approximately 50 days and the reported samples have not been returned for investigative analysis.These parts are manufactured and packaging at coopersurgical.This particular part was manufactured in june 2015 and shipped to the customer in (b)(6) 2015.A review of the dhr did not show any abnormalities.A review of two year complaint history shows one similar complaint for this issue that was not confirmed.There are no finished goods inventory of the reported lot number.A sampling and visual inspection of two other finished goods lot numbers (166993 and 166996) did not reveal any issues.As part of the molding process, there is extra material on the outside diameter of the pessary ring.At the subsequent secondary operation, the extra material is buffed off.In addition, prior to packaging, each pessary is visually inspected for non-conformances.The dhr confirms the buffing operation and the visual inspection prior to packaging were conducted.Based on the reported sample not being returned and the investigation stated above, the cause of the issue cannot be reliably determined and has not been confirmed.*correction and/or corrective action : none at this time.Will continue to monitor for trending.However, this complaint will be reopened and re-evaluated should the samples be returned.

Event Description

"flash from the mold process that made me bleed." (b)(4).

• Brand Name: KIT-RING W/SUPP.#4 70MM
• Type of Device: PESSARY KIT-RING W/SUPP.#4 70MM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5613142
• MDR Text Key: 44583947
• Report Number: 1216677-2015-00081
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Model Number: MXKPRS04
• Device Catalogue Number: MXKPRS04
• Device Lot Number: 157526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other