MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS

Catalog Number	DYNJP3008UG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
"shortly after the surgery, the owner began sharing concerns surrounding the incision site, starting with small oozing at the cranial edge, to a widespread infection along the entire site.".
Additional Manufacturer Narrative
It was reported that "during surgery the laparotomy drape in question was opened using aseptic technique and given to the surgeon who was sterile at that time.The surgeon placed the drape so that the opening in the center of the drape was aligned with where the incision along the spine was made.From there, the surgeon began performing the procedure.The drape in question was being used as a shield to maintain the sterile field around the incision site.Shortly after the surgery, the owner began sharing concerns surrounding the incision site, starting with small oozing at the cranial edge, to a widespread infection along the entire site".It was reported, "the patient had been treated with antibiotics to help with the infection but ended up having an adverse reaction to the antibiotics.The patient was then hospitalized for multiple days at a rockford er to recover from the reaction." the patient in the complaint is a dog.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.
Additional Manufacturer Narrative
Updated: d2b.
Additional Manufacturer Narrative
Updated h6.Recall - r-26-003.

• Common Device Name: DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS
• 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: 24808799
• Report Number: 1417592-2026-00379
• Device Sequence Number: 21509770
• Product Code: PUI
• UDI-Device Identifier: 10080196573783
• UDI-Public: 10080196573783
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: DYNJP3008UG
• Device Lot Number: 72524080036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: Not provided; 04/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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 Age: 6 YR
• Patient Sex: Male
• Patient Weight: 16 KG