MAUDE Adverse Event Report: MEDLINE INDUSTRIES MAJOR LAP PACK; LAPAROSCOPY KIT

Lot Number 17T86454

Device Problem Material Discolored (1170)

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

Event Type  malfunction  

Event Description

Medline major lap pack chs-l; discolored lap sponges (yellow).

• Brand Name: MAJOR LAP PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES ; mundelein
• MDR Report Key: 8448139
• MDR Text Key: 139736685
• Report Number: MW5085101
• Device Sequence Number: 0
• Product Code: FDE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Lot Number: 17T86454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1