MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL ORTHO U DRAPE 10; SURGICAL DRAPES AND PACKS

Model Number	89347
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient experienced an allergic reaction to the drape resulting in a rash on the chest, buttocks, and both the upper and lower abdomen.The patient sought medical treatment which included oral steroids and a topical steroid cream applied for several weeks.The patient is known to have allergies to adhesive and dermabond.
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.
Additional Manufacturer Narrative
The device was unavailable for return and subsequent analysis.The investigation team conducted a thorough analysis of the product complaint, focusing on identifying the root cause and assessing potential risks.Despite limited evidence, including a single image without accompanying batch information or physical samples, the team reviewed manufacturing records, quality control data, and product specifications.The drape in question utilizes solventum tape, a double-coated acrylate adhesive on polyethylene film with a silicone-treated paper liner, produced in a facility compliant with fda regulations and certified under iso 9001 and 13485 standards.Toxicological and clinical evaluations confirm the product's safety profile, demonstrating it to be non-irritant, non-sensitizing, and non-cytotoxic.The investigation found no direct correlation between the reported adverse reactions and the product's formulation or manufacturing process.Overall, the product maintains its compliance with safety and quality standards, and no modifications are warranted at this time.Responses to customer questionnaire indicate the patient also has a known allergic reaction to adhesives and dermabond.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.

• Brand Name: SURGICAL ORTHO U DRAPE 10
• Common Device Name: SURGICAL DRAPES AND PACKS
• 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: 23017209
• Report Number: 3005997949-2025-00006
• Device Sequence Number: 9769450
• Product Code: PUI
• UDI-Device Identifier: 30680651893476
• UDI-Public: 30680651893476
• Combination Product (Y/N): N
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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 Model Number: 89347
• Device Catalogue Number: 991089347
• Device Lot Number: UNKNOWN
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown