MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FAK,COMPLETE,CURAD,175PC/KIT

Catalog Number	CURFAK300RV1H
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ice pack that came inside item curfak300rv1h- fak,complete,curad,175pc/kit exploded within the first aid kit and got everything wet inside.
Additional Manufacturer Narrative
The customer reported that the ice pack that came inside the first aid kit exploded within the first aid kit and got everything wet inside.At this time, a sample(s) was not received for this complaint, and without a physical sample or picture, this limits the ability to investigate the issue thoroughly and establish a root cause for the reported defect; 6 months of complaint history was evaluated and there were two similar complaints for this issue from this vendor.Due to this, the complaint was not confirmed, and a root cause was not established.The vendor is aware of this issue and noted that they began to implement change, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: FAK,COMPLETE,CURAD,175PC/KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50763068
• Report Number: 1417592-2026-39995
• Device Sequence Number: 9195529
• Product Code: LRR
• UDI-Device Identifier: 00193489100351
• UDI-Public: 00193489100351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CURFAK300RV1H
• Device Lot Number: 10605231028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown