MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. OR MINOR PACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number DYNJ49355

Device Problem Component Missing (2306)

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

Event Date 03/23/2019

Event Type  malfunction  

Event Description

Only 4 of the 5 indicated "lap sponge 12x12" were present in the medline industries minor pack upon opening.

• Brand Name: OR MINOR PACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 8460149
• MDR Text Key: 140438506
• Report Number: MW5085278
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2019

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: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: DYNJ49355
• Device Catalogue Number: DYNJ49355
• Device Lot Number: 19BBC868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• 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 Age: 49 YR