MAUDE Adverse Event Report: Medline Industries, LP Medline; GENERAL SURGERY PACK

Catalog Number	DYNJ62917B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, "gowns bleeding through the material.Today one of our doctors had an allergic reaction and broke out in hives".
Additional Manufacturer Narrative
It was reported that on (b)(6)2026, "gowns bleeding through the material.Today one of our doctors had an allergic reaction and broke out in hives".According to the facility, "surgeon used the gown during a thoracotomy.Gown was worn for a duration of approximately 2 hours before they requested a new gown due to feeling wet.When gown was taken off, surgeons forearms were stained red with blood from patient.A skin rash was seen on surgeon once they washed soil off of themselves".It was reported that there was no follow up care or treatment required.No additional details are available related to the customer reported issue.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: GENERAL SURGERY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50115995
• Report Number: 1423395-2026-00462
• Device Sequence Number: 21332880
• Product Code: LRO
• UDI-Device Identifier: 10195327266196
• UDI-Public: 10195327266196
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ62917B
• Device Lot Number: 26CMJ223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• 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: Female