MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP SURGICAL DRAPE; DRAPE,HIP,W/POUCH,ST,5/CS

Catalog Number	DYNJP8201
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2025, a surgical site infection occurred in a patient who underwent a total hip replacement.The facility reported that the drape model tore during the draping process on multiple occasions, leading surgeons to refuse continued use of the product.Wound cultures were obtained and the patient required return to surgery for incision/drainage of the affected hip.At the time of the report, the patient remained in the recovery period and continued to follow up with the surgeon.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, a surgical site infection occurred in a patient who underwent a total hip replacement.The facility reported that the drape model tore during the draping process on multiple occasions, leading surgeons to refuse continued use of the product.Wound cultures were obtained and the patient required return to surgery for incision/drainage of the affected hip.At the time of the report, the patient remained in the recovery period and continued to follow up with the surgeon.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.

• Brand Name: SURGICAL DRAPE
• Common Device Name: DRAPE,HIP,W/POUCH,ST,5/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24260771
• Report Number: 1417592-2026-00085
• Device Sequence Number: 21273851
• Product Code: PUI
• UDI-Device Identifier: 10080196740765
• UDI-Public: 10080196740765
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJP8201
• Device Lot Number: 45025070285
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: 61 YR
• Patient Sex: Female