MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD U-DRAPES; SURGICAL DRAPES

Model Number	48057
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is not available for evaluation.A follow-up report will be provided upon conclusion of the investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The patient experienced abrasions and bruising upon removal of the drape.Additional information has been requested regarding this incident; however, no response has been received.
Additional Manufacturer Narrative
No samples or photographs were provided for evaluation; therefore, the reported issue could not be confirmed.The device history record for the associated lot was reviewed and verified that all manufacturing and quality requirements were met prior to release.No rework activities or special conditions were documented.Trend analysis indicates no recurring issues related to drape abrasion.There were no reported incidents from january 2025 through january 2026, with only two incidents recorded in february 2026.The complaint was forwarded to the appropriate functional area for investigation and root cause assessment.A comprehensive review of manufacturing records, quality systems, and complaint history identified no abnormalities or quality concerns.Abrasion is a known, low-risk characteristic associated with surgical drapes and may occur during normal use due to patient movement or contact with the material.The product materials, including adhesive tape and fabric, are validated for medical use and comply with all applicable regulatory and biocompatibility standards, including non-irritating, non-sensitizing, and non-cytotoxic classifications.No recent material or process changes have been implemented.Based on the available information, no product performance or manufacturing-related issue was identified.Relevant personnel have been notified to ensure awareness of the reported incident.This product incident is documented in the o&m halyard, inc.Complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD U-DRAPES
• Common Device Name: SURGICAL DRAPES
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col. educativa, nogales sonora
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24428304
• Report Number: 3005997949-2026-00002
• Device Sequence Number: 10113211
• Product Code: PUI
• UDI-Device Identifier: 30680651480577
• UDI-Public: 30680651480577
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48057
• Device Catalogue Number: 48057
• Device Lot Number: AC2526103F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown