MAUDE Adverse Event Report: CARDINAL HEALTH / CARDINAL HEALTH 200, LLC HAMOT MINOR VAGINAL PACK; GYNECOLOGICAL LAPAROSCOPIC KIT

Catalog Number SMA4EMVHTB

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

When opening for a surgical case it was noted that a wood chip like item was found in a sterile pack - making it not sterile, new pack was obtained.

• Brand Name: HAMOT MINOR VAGINAL PACK
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH / CARDINAL HEALTH 200, LLC
• MDR Report Key: 18257733
• MDR Text Key: 329721828
• Report Number: MW5148708
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10197106373620
• UDI-Public: (01)10197106373620
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SMA4EMVHTB
• Device Lot Number: 148930
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1