MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYONE MUSHROOM CUP BOX OF 12; FOETAL VACUUM EXTRACTION SYSTEM CUP

Model Number	10067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an infant sustained diffuse scalp hyperdense swelling in the left temporoparietal and posterior parieto-occipital region upon birth.The mityone vacuum system was used during delivery.Initial diagnosis so far is that there no acute infarcts or brain hemorrhage.Infant was admitted to the nicu.No additional information is available.100670 mityone (b)(4).
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 07/03/2023 under work order (b)(4) and shipped on 07/19/2023.Manufacturing record review: dhr-10067- 335530 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product has not been returned to cooper surgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.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 cooper surgical.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.These adverse events are identified in the ifu and may also occur while navigating the pelvis during delivery.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information is available.

• Brand Name: MITYONE MUSHROOM CUP BOX OF 12
• Common Device Name: FOETAL VACUUM EXTRACTION SYSTEM CUP
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19608482
• Report Number: 1216677-2024-00028
• Device Sequence Number: 8204935
• Product Code: HDB
• UDI-Device Identifier: 00888937003123
• UDI-Public: (01)00888937003123(10)335530(17)260605
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2026
• Device Model Number: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 335530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown