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	Unspecified Infection (1930)
Date of Event	11/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, a "surgical site infection" was reported following a total hip replacement on (b)(6) 2025 where the drapes tore during the procedure.The customer reported that the patient was "taken back to surgery for incision & drainage" of the affected hip where "wound cultures" were taken.The customer stated that the patient will "be seen in office" on (b)(6) 2026 for surgical follow-up.No additional information is available at this time.It has been determined that the reported event caused or contributed to (death/serious injury), therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, a "surgical site infection" was reported following a total hip replacement on (b)(6) 2025 where the drapes tore during the procedure.The customer reported that the patient was "taken back to surgery for incision & drainage" of the affected hip where "wound cultures" were taken.

• Brand Name: SURGICAL DRAPE
• Common Device Name: DRAPE,HIP,W/POUCH,ST,5/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24223639
• Report Number: 1417592-2026-00076
• Device Sequence Number: 8579444
• Product Code: PUI
• UDI-Device Identifier: 10080196740765
• UDI-Public: 10080196740765
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJP8201
• Device Lot Number: 45025070285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/30/2026
• 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: 49 YR
• Patient Sex: Male