MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYVAC PEARL EDGE BELL CUP; EXTRACTOR, VACUUM, FETAL

Model Number 10004

Patient Problem Hematoma (1884)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

Failed vacuum extraction for delivery of newborn resulting in a large hematoma.Company notified the organization that the item was back-ordered and it was acceptable to use an outdated item.

• Brand Name: MITYVAC PEARL EDGE BELL CUP
• Type of Device: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 18486346
• MDR Text Key: 332802342
• Report Number: MW5150079
• Device Sequence Number: 1
• Product Code: HDB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: 10004
• Device Lot Number: 286151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White