MAUDE Adverse Event Report: COOPERSURGICAL, INC. PEARL EDGE BELL CUP; EXTRCTR CUP,PEARL EDG BEL W/FILTER

Model Number	10004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch report that was found in the maude database: failed vacuum extraction for delivery of newborn resulting in a large hematoma.Allegedly, the company notified the organization that the item was back-ordered and it was acceptable to use an outdated item.1216677-2024-00044 10004 pearl cup 2024-08-0000184.
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi on 06-10-2020.Manufacturing record review: dhr-10004 - 286151 was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history showed no reported complaints for this part.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: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action in necessary, as the complaint condition was not confirmed.

• Brand Name: PEARL EDGE BELL CUP
• Common Device Name: EXTRCTR CUP,PEARL EDG BEL W/FILTER
• 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: 20028946
• Report Number: 1216677-2024-00044
• Device Sequence Number: 7448170
• Product Code: HDB
• UDI-Device Identifier: 00888937003031
• UDI-Public: 00888937003031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: 10004
• Device Catalogue Number: 10004
• Device Lot Number: 286151
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White