MAUDE Adverse Event Report: MEDLINE INDUSTRIES MAJOR ABDOMINAL PACK; PACK, SURGICAL

Catalog Number DNYJ17487C

Device Problem Split (2537)

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

Event Date 10/12/2016

Event Type  malfunction  

Event Description

There was a light glove that was put onto surgical light.When light glove was moved a split in the glove was detected and light glove was quarantined.

• Brand Name: MAJOR ABDOMINAL PACK
• Type of Device: PACK, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein IL 60060
• MDR Report Key: 6212833
• MDR Text Key: 63534916
• Report Number: 6212833
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DNYJ17487C
• Device Lot Number: 16HD1132
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR