MAUDE Adverse Event Report: DUKAL CORPORATION REGARD; SPONGE LAP X-RAY DET

Model Number 236354REG

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Lap sponge with loose shredding fibers.

• Brand Name: REGARD
• Type of Device: SPONGE LAP X-RAY DET
• Manufacturer (Section D): DUKAL CORPORATION; ronkonkoma NY
• Manufacturer Contact: cheyenne stewart ; 645 maryville centre drive; ste 200; st. louis, MO 63141
• MDR Report Key: 9454665
• MDR Text Key: 194321735
• Report Number: 3004513970-2019-00002
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2019

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 Operator: Health Professional
• Device Model Number: 236354REG
• Device Catalogue Number: 236354REG
• Device Lot Number: LK22018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1