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

Catalog Number	DYNJ41565J
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on (b)(6), "provider noted after cesarean section that patient had a macular rash in the distribution of c-section drape.".
Additional Manufacturer Narrative
According to the customer on 2/15, "provider noted after cesarean section that patient had a macular rash in the distribution of c-section drape.Per discharge summary on (b)(6) 2024 "she did have a rash in the distribution of the drape adhesive and was treated with antihistamine and topical steroid".The was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: C-SECTION PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19267384
• Report Number: 1423395-2024-00411
• Device Sequence Number: 20706535
• Product Code: OHM
• UDI-Device Identifier: 40195327555673
• UDI-Public: 40195327555673
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/08/2024

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: DYNJ41565J
• Device Lot Number: 24AMH289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/08/2024
• 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