MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; KNEE ANKLE FOOT PACK

Catalog Number DYNJ81430B

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient had a "severe allergic reaction after an acl surgery" to the pad used.It was reported that due to this "treatment was provided by the providers".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

Severe reaction.

• Type of Device: KNEE ANKLE FOOT PACK
• 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: 19213065
• MDR Text Key: 341387499
• Report Number: 1423395-2024-00404
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10195327321659
• UDI-Public: 10195327321659
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ81430B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male