MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BASIN SET

Catalog Number DYNJ50906B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during use of the insulated tip cautery pencil in a breast augmentation procedure, the patient sustained skin burn within the incision site.General anesthesia was used; however there was no effect on the patient's stability as a result of the incident.The sample has been returned and evaluated including an insulated tip that was not a part of the pre-packaged basin set pack.During sample evaluation, the cautery pencil functioned without an issue on dispersion of heat or current from the cautery blade beyond point of contact.A root cause cannot be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the patient sustained skin burn within the incision site during use of insulated tip cautery pencil.

• Type of Device: BASIN SET
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7252134
• MDR Text Key: 99362982
• Report Number: 1423395-2018-00001
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942464883
• UDI-Public: 10889942464883
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ50906B
• Device Lot Number: 17KDO726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 47