MAUDE Adverse Event Report: CARDINAL HEALTH RAYTEC SPONGES; VAGINAL CUSTOM PACK

Catalog Number SMA73VDSVI

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Product pack says contains 10 raytec sponges and only contained 8 raytec sponges.

• Brand Name: RAYTEC SPONGES
• Type of Device: VAGINAL CUSTOM PACK
• Manufacturer (Section D): CARDINAL HEALTH; 7000 cardinal place; dublin OH 43017
• MDR Report Key: 6986532
• MDR Text Key: 90678813
• Report Number: MW5073013
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMA73VDSVI
• Device Lot Number: 730561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1