MAUDE Adverse Event Report: COOPERSURGICAL, INC. PESS.SH.STEM FLEX 3-1/4

Model Number MXPGSS3-1/4

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Vaginal Mucosa Damage (2124); Discharge (2225); Fluid Discharge (2686); Genital Bleeding (4507)

Event Date 07/04/2019

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

Patient with brownish discharge.Difficulty to remove at clinic o/e tissue noted to bleeding and erosion noted.Ref (b)(4).

Event Description

Healthcare professional reported patient with "brownish discharge," "difficulty to remove at clinic," upon examination "tissue noted to bleeding and erosion noted." treatment with gynest cream.Ref e-complaint-(b)(4).

Manufacturer Narrative

Clarification to h.6.Component code: unit is a one-piece pessary.Investigation: 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 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 (see attachments for certs over the past year).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.Corrective action: engineering project has been requested to determine if customer observations with regard to pessary durometer warrant further product enhancements.

• Brand Name: PESS.SH.STEM FLEX 3-1/4
• Type of Device: PESS.SH.STEM FLEX 3-1/4
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corprate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 9342865
• MDR Text Key: 191395131
• Report Number: 1216677-2019-00299
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXPGSS3-1/4
• Device Catalogue Number: MXPGSS3-1/4
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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