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 Codes	Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on 1/12, "morning of post op day 4 there was noted to be erythema surrounding the incision as well as perineum and spreading to lower abdomen.".
Additional Manufacturer Narrative
According to the customer on 1/12, "morning of post op day 4 there was noted to be erythema surrounding the incision as well as perineum and spreading to lower abdomen.She had a rash higher up on abdomen as well in distribution of drape adhesive.She states that she has very sensitive skin.Felt itchy on abdomen and all over.The incision appeared intact and there was no drainage, she was afebrile, pain was minimal, and she was only taking tylenol and ibuprofen.Erythema seems to be more due to inflammation as opposed to a wound infection.Keflex prescribed as a precaution".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: 19267209
• Report Number: 1423395-2024-00410
• Device Sequence Number: 7384027
• 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