MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 2-3/4 IN #3

Model Number MXPDO03

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

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

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).

Event Description

Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert." (b)(4).Donut pess 2-3 4 in no 3 mxpdo03.

Manufacturer Narrative

*investigation x-initiated manufacturer's investigation x-review dhr x-inspect stock product.*analysis and findings ref: (b)(4).Distribution history the complaint product was purchased from a supplier (eis), packaged by csi in may 2011 under work order 103801.Manufacturing record review a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Historical complaint review a review of the 2-year complaint history did not show any other complaints for this issue.Root cause quality engineering, manufacturing, marketing, and product surveillance conducted an investigation into the recent complaints regarding the hardness and rigidity of the pessary product line.There have been no specification changes in the last 2 years.Returned product from historical complaint investigations and sample product from finished goods inventory were evaluated and the reported condition could not be duplicated.The products were found to meet all approved release specifications.The reported complaint condition could not be confirmed.Corrective action: capa 735 has been opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.

Event Description

Report stated - "issue with each of them pertaining to texture (to hard), color, stiffness, ease of use.The customer has had ongoing issue with the listed pessaries not being able to insert." ref (b)(4).1216677-2020-00111 donut pess 2-3 4 in no 3 mxpdo03 (b)(4).

• Brand Name: DONUT PESS 2-3/4 IN #3
• Type of Device: DONUT PESS 2-3/4 IN #3
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct
• MDR Report Key: 9999497
• MDR Text Key: 194942680
• Report Number: 1216677-2020-00111
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/26/2020

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: Health Professional
• Device Model Number: MXPDO03
• Device Catalogue Number: MXPDO03
• Device Lot Number: 103801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other