MAUDE Adverse Event Report: COOPERSURGICAL, INC. KIT SHORT STEM FLEX 2-1/4

Model Number MXKPGSS2-1/4

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc is currently investigating the condition reported.

Event Description

(b)(4).Report stated "the labels of the ordered pessaries (gellhorn shorts 2 1/4") were correct but the pessaries inside of each box came gellhorn regular 2 1/4".Kit short stem flex 2-1 4 mxkpgss2-1 4 (b)(4).

Event Description

Report stated "the labels of the ordered pessaries (gellhorn shorts 2 1/4") were correct but the pessaries inside of each box came gellhorn regular 2 1/4" 1216677-2021-00019-1 kit short stem flex 2-1-4 mxkpgss2-1-4 e-complaint-2021-02-0000012.

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned review dhr inspect stock product *analysis and findings distribution history the complaint product was manufactured at csi in may 2020 under work order 276529.Manufacturing record review (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.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.However, there were finished goods product of the reported lot number available for evaluation.Visual evaluation visual examination of finished goods inventory for this lot number found the parts inside the package were as described in the reported complaint, long stem gellhorn were inside instead of short stem gellhorn.Functional evaluation complaint product was functionally evaluated and found to function properly.Root cause the wrong molds were used to mold the product.Capa 746 and ncmr 13431 were opened.*correction and/or corrective action capa 746 and ncmr 13431 coopersurgical will continue to monitor this complaint condition for trends.Train personnel *was the complaint confirmed? yes.

• Brand Name: KIT SHORT STEM FLEX 2-1/4
• Type of Device: KIT SHORT STEM FLEX 2-1/4
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11358132
• MDR Text Key: 234426933
• Report Number: 1216677-2021-00019
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: MXKPGSS2-1/4
• Device Catalogue Number: MXKPGSS2-1/4
• Device Lot Number: 276529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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