MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CAUTERY DEVICE IN C-SECTION PACK

Catalog Number DYNJ41993A

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

It was reported a cautery device caused a burn to an end-user during use.Facility was contacted for additional information and stated it was determined the cautery device was not the cause of the burns.Facility stated "the issue was more likely to have been caused by an issue with the wall panel." the facility gave no further details in regards to the injury, use of the cautery device, generator settings, or specifics in regards to the "wall panel." at this time the reported injury cannot be verified and the complaint cannot be confirmed.A sample was not returned and a root cause cannot be determined.Due to the reported incident and in an abundance of caution this medwatch is being filed.Device not returned.

Event Description

It was reported a cautery device caused a burn to an end-user.

• Type of Device: CAUTERY DEVICE IN C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6608408
• MDR Text Key: 76540297
• Report Number: 1423395-2017-00018
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ41993A
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other