MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY

Lot Number 49668108

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

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

Event Date 06/27/2019

Event Type  malfunction  

Event Description

Sterile icd pacemaker tray wrapper found to have hole at area of wrapper seal.Appears to have pulled off backing when seal was torn.Did not reach patient.Supply comes prepackaged and the hole may have been a result of the seal being broken, but not clear.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 8850687
• MDR Text Key: 152943017
• Report Number: 8850687
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 49668108
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1