MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; BREAST AUGMENTATION PACK

Catalog Number	DYNJ88195
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Discomfort (2330); Blister (4537)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer contact, "early 2026-ongoing", "patients experience significant dermatologic reactions associated with the bordered gauze included in our custom packs.".
Additional Manufacturer Narrative
According to the customer contact, "early 2026-ongoing", "patients experience significant dermatologic reactions associated with the bordered gauze included in our custom packs." the customer contact reported, "our standard postoperative process is to apply steri-strips followed by the bordered gauze, and patients are returning with concerning symptoms such as rash, blistering, pruritus, and associated discomfort." the customer contact reported this has happened to "multiple patients".The customer contact reported "dressing change" and "f/up care to address the dermal side effects and to prevent scarring" had been required.Following the reported incident, the customer contact noted there was "improvement to dermis with removal of bordered gauze" and stated, "will continue to monitor for long term effects." per the customer contact, "for patient safety and quality-of-care reasons, we are looking to make adjustments to our postoperative dressings to help prevent these reactions." no additional information is available regarding the customer reported incident.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: BREAST AUGMENTATION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25111971
• Report Number: 1423395-2026-00132
• Device Sequence Number: 13084649
• Product Code: FTN
• UDI-Device Identifier: 10198459118425
• UDI-Public: 10198459118425
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/07/2026

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: DYNJ88195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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