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

Catalog Number 89-10560.01

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Deroyal laparotomy pack was opened on case prior to patient being in the room.Did not delay case.Lap sponge band was broken.Picture was obtained of lap sponges and pack list, sent to quality.Laps with broken band not saved.Laps discarded out of or room.Separate pack of laps opened to field.

• Brand Name: CMC LAPAROTOMY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11607340
• MDR Text Key: 243576189
• Report Number: 11607340
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-10560.01
• Device Lot Number: 53634904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1