MAUDE Adverse Event Report: DUKAL REGARD; SPONGE LAP XRAY DET

Lot Number LK34118

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

This item is manufactured by dukal and is private labeled with the regard brand.This item is not manufactured by roi.

Event Description

Pieces of lap sponge broke off and were left in a patient.

• Brand Name: REGARD
• Type of Device: SPONGE LAP XRAY DET
• Manufacturer (Section D): DUKAL; 2 fleetwood court; ronkonkoma NY 11779
• Manufacturer (Section G): RESOURCE OPTIMIZATION & INNOVATION; 2909 n. neergard; springfield MO 65803
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 8809441
• MDR Text Key: 162056910
• Report Number: 3004513970-2019-00001
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: LK34118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1