MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD IMPERVIOUS OPEN-BACK GOWN BLUE KNIT CUFFS LARGE; PROTECTIVE APPAREL

Model Number	69455
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) unused representative sample was received and evaluated.No abnormalities were noted, gown met product specifications.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard impervious open-back gown blue knit cuffs large.The part number 69455 is contract manufactured by andersen industries co.Ltd., (fda registration number 3015960676).Supplier corrective action request (scar) was submitted to the manufacturer on january 30, 2026.The device history record (dhr) for the complaint lot was reviewed in its entirety, and no abnormalities or deviations were identified.The product met all established inspection and release criteria at the time of manufacture.There have been no changes to the product design, raw materials, or manufacturing processes associated with product.Additionally, the contract manufacturer confirmed that no new personnel were assigned to the production line during the manufacture of this lot.This is the first complaint of this nature associated with this gown.A review of complaint data confirms that there is no adverse trend related to this issue.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
On (b)(6), a staff member experienced strikethrough on the forearm that resulted in a chemical burn.The employee washed the affected area with mild soap and water and completed the remainder of the shift.The incident was reported to employee health; however, to the manager¿s knowledge, the employee was not prescribed any additional treatment or further evaluation.The employee returned to work on (b)(6) with no medical treatment reported.At the time of the incident, the employee was wearing medline gloves.The burn occurred above the glove line.It is currently unclear whether the reaction was caused by the chemical in use, the gown sleeve, or the gloves.The employee is known to have a general allergy sensitivity.The chemical being used at the time of the occurrence was ecolab multi-enzymatic concentrated detergent.The manager stated the facility has used the same gown style for more than eight years.Staff members change gowns three times during an eight-hour shif; twice for 15-minute breaks and once for a lunch break.Employees in this area are routinely exposed to heavy fluid levels.

• Brand Name: HALYARD IMPERVIOUS OPEN-BACK GOWN BLUE KNIT CUFFS LARGE
• Common Device Name: PROTECTIVE APPAREL
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): ANDERSEN INDUSTRIES CO., LTD.; national road.4; srah sangkom srassangkom; peuk, commune angsnoul, kandal province 08315 ; CB 08315
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24394019
• Report Number: 3014421917-2026-00004
• Device Sequence Number: 21297738
• Product Code: OEA
• UDI-Device Identifier: 30680651694554
• UDI-Public: 30680651694554
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 02/19/2026

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: 69455
• Device Catalogue Number: 69455
• Device Lot Number: KA25203005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/19/2026
• 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