MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYONE MUSHROOM CUP

Model Number	10067
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Incident report: we had a mityvac mushroom cup style# 10067, lot# 290007 fail during a delivery overnight at (b)(6).The device broke apart where the suction cup and stem are connected and the suction cup remained on the baby's head after it broke.A new device was applied and the delivery was completed without harm to the baby.The packaging was retrieved, but unfortunately the device itself was discarded.Mityone mushroom cup 10067 e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned review dhr distribution history the complaint product was manufactured at csi under work order (b)(4).Manufacturing record review dhr-10067 - 290007 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 was not returned to csi.Visual evaluation an 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 an 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 root cause not applicable as the complaint condition was not confirmed.Corrective actions complaint unit has not been returned to coopersurgical so the complaint could not be confirmed.Coopersurgical will continue to trend this complaint condition.No further corrective actions necessary.No further required at this time, complaint will be monitored for trending.Was the complaint confirmed? no.
Event or Problem Description
Customer stated: "we had a mityvac mushroom cup fail during a delivery overnight.The device broke apart where the suction cup and stem are connected and the suction cup remained on the baby's head after it broke.A new device was applied and the delivery was completed without harm to the baby.The packaging was retrieved, but unfortunately the device itself was discarded".1216677-2020-00230-1 10067 mityone mushroom cup (b)(4).

• Brand Name: MITYONE MUSHROOM CUP
• Common Device Name: MITYONE MUSHROOM CUP
• 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: 10656140
• Report Number: 1216677-2020-00230
• Device Sequence Number: 2949775
• Product Code: HDP
• UDI-Device Identifier: 00888937003123
• UDI-Public: 888937003123
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 290007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown