MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL LAPAROTOMY DRAPE W/TROUGHS 13; SURGICAL DRAPES AND PACKS

Model Number	89234
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product.The product is contract manufactured by lianyungang aiyeh non-woven products co., ltd.(fda registration number 3004713352).A scar was issued to the contract manufacturer on november 25, 2024.A follow-up report will be provided upon conclusion of 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The clinician noticed after a procedure that 10 cm of epidermal peeling and blistering occurred on the patient, resulting in medical intervention.An application of prope to was applied to the patient's skin.
Additional Manufacturer Narrative
This is the first complaint for allergic reaction from dec 2023 to dec 2024 (12-month evaluation period).Neither a complaint lot number nor a sample was received.The last 12 months of product production lots were reviewed and found to be manufactured according to specifications.No defects were detected during process inspections.The manufacturer has made no changes to the 3m 1509 tape component utilized in this product since 2023.There has been no manufacturing or sterilization process changes in recent two years.No additional actions will be implemented at this time; however, we will continue to closely monitor field performance to identify emerging trends which may warrant corrective actions.No root cause was identified.

• Brand Name: SURGICAL LAPAROTOMY DRAPE W/TROUGHS 13
• 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): LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD.; no. 9 yunyang rd; lianyungang economic and technological development; lianyungang jiangsu, cn 22204 7; CH 222047
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20938816
• Report Number: 3014421917-2024-00022
• Device Sequence Number: 14568880
• Product Code: PUI
• UDI-Device Identifier: 30680651892349
• UDI-Public: 30680651892349
• 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): 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): 01/08/2025

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: 89234
• Device Catalogue Number: 89234
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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 Age: 63 YR
• Patient Sex: Male