MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NORTH CERVICAL PACK-LF

Catalog Number DYNJ56425C

Device Problem Defective Component (2292)

Patient Problem Burn(s) (1757)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that on (b)(6) 2020, a bovie/cautery tip malfunctioned causing a burn to a patient's neck during an anterior cervical discectomy & fusion (acdf) of c3-c7 procedure.The reporter states bacitracin ointment and adaptec dressing were applied post surgically.It was further reported that it is "unknown if the surgeon had ordered additional follow-up care." the reporter states the sample will be kept by the facilities risk management.As a result, the sample is not available for return and evaluation.Therefore, a true root cause could not be determined at this time.A picture was provided.There is no further information at this time.Due to the report of a burn, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported a bovie/cautery tip malfunctioned causing a burn to a patient's neck.Bacitracin ointment and adaptec dressing were applied post surgically.

• Type of Device: NORTH CERVICAL PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10356602
• MDR Text Key: 201857087
• Report Number: 1423395-2020-00017
• Device Sequence Number: 1
• Product Code: OJH
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ56425C
• Device Lot Number: 311985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 64