MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACH ULTRA FREEZE

Model Number	900076
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Leaking, inconsistent trigger, inconsistent spray pattern, frosting confirmed complaint: bottle lost vacuum.Replaced bottle assembly, cleaned valve repair order 98052 1216677-2022-00099 wallach ultra freeze 900076 e-complaint-(b)(4).
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
Leaking, inconsistent trigger, inconsistent spray pattern, frosting.Confirmed complaint: bottle lost vacuum, replaced bottle assembly, cleaned valve.Repair order (b)(4).1216677-2022-00099 wallach ultra freeze 900076 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation x-review dhr x-inspect returned samples analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 02/18/2014 under wo # (b)(4) and shipped on 02/28/2014.Manufacturing record review: dhr-154472 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: while no definitive root cause could be reliably determined, the potential cause may be that the unit was dropped or it could be normal wear and tear.Correction and/or corrective action the bottle was replaced and the valve was cleaned.The unit was tested and found to be acceptable and was returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.
Event or Problem Description
Healthcare professional reported "leaking, inconsistent trigger, inconsistent spray pattern, frosting." company representative confirmed "bottle lost vacuum.".
Additional Manufacturer Narrative
Investigation findings: this complaint unit was manufactured at csi on 18/feb/2014 and shipped on 28/feb/2014.Device history record was reviewed, and no non-conformities related to the complaint condition were noted.No additional service history records were found for this unit.A review of the two-year history of the same part number showed similar reported complaint condition.The complaint unit was returned on a repair on 11/mar/2022.Visual examination of the complaint unit revealed no physical damage, however, functional evaluation of the unit showed the unit did not function properly.The unit had lost its vacuum.Root cause: while no definitive root cause could be reliably determined, the potential cause may be that the unit was dropped or it could be normal wear and tear.

• Brand Name: WALLACH ULTRA FREEZE
• Common Device Name: WALLACH ULTRA FREEZE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 50 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 95 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 13964873
• Report Number: 1216677-2022-00099
• Device Sequence Number: 3914051
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K935010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2023

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 Model Number: 900076
• Device Catalogue Number: 900076
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 03/11/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 09/20/2022; 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown