MAUDE Adverse Event Report: COOPERSURGICAL, INC. PESS.SH.STEM FLEX 2-3/4

Model Number MXPGSS2-3/4

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved will not be returned by the customer for evaluation.Once the investigation has been completed a follow-up report will be filed.

Event Description

Removal of pessary due to vaginal bleeding and erosion.Patient does not wish re-insertion.Ref (b)(4).

Event Description

Removal of pessary due to vaginal bleeding and erosion.Patient does not wish re-insertion.(b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation, x-no sample returned.Analysis and findings: distribution history: since the lot number was not provided, it is not clear when the product was manufactured and purchased.Manufacturing record review: a review of the device history record could not be performed because the lot number was not provided.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 complaint unit/product lot be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the attached 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.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.It should be noted that this product was originally manufactured for coopersurgical by a supplier (eis) until mid-2017.Manufacturing was moved to coopersurgical and validated in november 2017 (val-16-0219) using a new silicone supplier.It is suspected the customer noticed the current production pessary was slightly harder than the previously received supplier pessary.It should also be noted that the current silicone supplier provides certifications on every shipment with durometer hardness testing per astm d2240 which verifies durometer specifications are met.Based upon an analysis of historical returned/complaint product, stock product, dhr review and certificates of conformance, the reported complaint condition could not be confirmed.Correction and/or corrective action: corrective action: engineering project# 134 has been requested to determine if customer observations with regard to pessary durometer warrant further product enhancements.*preventative action activity engineering project# 134 has been requested via tech.Operations/engineering smartsheet.Coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: PESS.SH.STEM FLEX 2-3/4
• Type of Device: PESS.SH.STEM FLEX 2-3/4
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 9335363
• MDR Text Key: 191398440
• Report Number: 1216677-2019-00295
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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: MXPGSS2-3/4
• Device Catalogue Number: MXPGSS2-3/4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other