MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DRAPE,C-SECTION,FEN,POUCH,WIRE,7/CS

Catalog Number	DYNJP6102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, "i had a patient recently who had a fairly significant reaction to the c- section drape adhesive (like the red/rash area was the exact shape of it).
Additional Manufacturer Narrative
According to the customer, "i had a patient recently who had a fairly significant reaction to the c- section drape adhesive (like the red/rash area was the exact shape of it).She ended up on prednisone dose taper pack and is 13 days out and it's still there but is much improved from what it was initially.There was no further information.Due diligence has been completed.No additional details are available related to the customer reported issue.The customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was requested for evaluation.No additional information is available.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: DRAPE,C-SECTION,FEN,POUCH,WIRE,7/CS
• 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: 19634133
• Report Number: 1417592-2024-00697
• Device Sequence Number: 20682813
• Product Code: PUI
• UDI-Device Identifier: 40080196908630
• UDI-Public: 40080196908630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/28/2024

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: DYNJP6102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/28/2024
• 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