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

Catalog Number APLS1106

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Skin Inflammation/ Irritation (4545)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that on (b)(6) 2023, 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, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Within three days of use the patient developed a "violent dermatitis".

• Type of Device: 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, IL 60093
• MDR Report Key: 18435742
• MDR Text Key: 331793314
• Report Number: 1417592-2024-00002
• Device Sequence Number: 1
• Product Code: NEC
• UDI-Device Identifier: 00618407611066
• UDI-Public: 00618407611066
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: APLS1106
• Device Lot Number: 72166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other