MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC. STD C SECTION PACK; CESAREAN SECTION TRAY

Model Number SMA4ECSHTB

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

When a pack was opened for procedure it was noticed to have a small hair, pack and hair saved for manager to send to company not used on patient.

• Brand Name: STD C SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 18238402
• MDR Text Key: 329481334
• Report Number: MW5148565
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/27/2023

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: SMA4ECSHTB
• Device Catalogue Number: SMA4ECSHTB
• Device Lot Number: 141711
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Patient Sequence Number: 1