MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC RAYTEC SPONGE; GAUZE / SPONGE, INTERNAL, X-RAY DETECTABLE

Lot Number 194995

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/30/2019

Event Type  Injury  

Event Description

Raytec sponge fell apart requiring wound washout.Fda safety report id# (b)(4).

• Brand Name: RAYTEC SPONGE
• Type of Device: GAUZE / SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8696031
• MDR Text Key: 148016134
• Report Number: MW5087317
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Lot Number: 194995
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 73