MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-C SECTION PACK-LF

Catalog Number	DYNJ0378325O
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the facility on 5/10 an abdominal rash was reported.Due to this, a medrol dose pack and cream was used.No additional information was provided related to the reported incident.The sample is reported to not be available for evaluation.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.
Event or Problem Description
Per the facility on 5/10 an abdominal rash was reported.

• Common Device Name: DBD-C SECTION PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 20148680
• Report Number: 1423395-2024-00466
• Device Sequence Number: 4248502
• Product Code: OHM
• UDI-Device Identifier: 40195327626977
• UDI-Public: 40195327626977
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 09/05/2024

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: DYNJ0378325O
• Device Lot Number: 24FBI141 & 24CBH142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/05/2024
• 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