MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MBO-SWABSTCK, BENZOIN TINCTURE, 1/PK, ST

Catalog Number	APLS1106
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Skin Inflammation/ Irritation (4545)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the customer contact that on 10/18/23, within three days of use the patient developed a "violent dermatitis" it was reported that oral steroids and antibiotics were required due to the incident as well as wound care due to wound dehiscence.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Within three days of use the patient developed a "violent dermatitis.

• Common Device Name: MBO-SWABSTCK, BENZOIN TINCTURE, 1/PK, ST
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield
• MDR Report Key: 18453405
• Report Number: 1417592-2024-00007
• Device Sequence Number: 15186266
• Product Code: NEC
• UDI-Device Identifier: 00618407611066
• UDI-Public: 00618407611066
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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 Catalogue Number: APLS1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown