MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. INSTANT WARM PACK LARGE 6X9IN SODIUM ACETATE SINGLE PT USE; PACK, HOT OR COLD, DISPOSABLE

Model Number	51775
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	Eye Burn (2523)
Type of Reportable Event	Serious Injury
Event or Problem Description
The nurse reported heat pack exploded all over mom and baby.She stated that she went into the room and immediately grabbed the baby to wash him off because he was covered in the contents from the heat pack.The patient stated she felt like her face was burning as the contents got into her left eye.The nurse immediately washed out the mom's eyes.The nurse stated she wanted to get the baby cleaned up quickly and have mom assessed by her ob doctor.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Incident one.The product involved in this event is not available for evaluation.Owens & minor distribution, inc.Is the initial importer and distributor of the medical device.The product is manufactured by rapid aid corporation, (fda registration number 9710505).A scar (supplier corrective action request) was issued on may 20, 2025.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the 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 product is defective or has caused serious injury.
Additional Manufacturer Narrative
Incident one: no lot number was provided by complaint reporter.Two recent lot retained samples were evaluated.The samples were found to meet temperature and pressure test specifications.There was no evidence of leakage during product activation and pressure test.A device history record review on the complaint product was unable to be conducted due to lack of lot number.The device history records were reviewed for last three lots, no manufacturing process issues were detected.One similar complaint was received for the product within the last 12 months.The incident was determined to be isolated based on tracking and trending data and in consideration of evaluation of retained samples and recent device history record review demonstrating no repeat of issue.This product incident is documented in the 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 product is defective or has caused serious injury.

• Brand Name: INSTANT WARM PACK LARGE 6X9IN SODIUM ACETATE SINGLE PT USE
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• Manufacturer (Section G): RAPID AID CORPORATION; 4120a sladeview crescent; mississauga ontario, canada
• Manufacturer Contact: nichole coggins ; 9120 lockwood blvd; mechanicsville, VA 23116 ; 8287820529
• MDR Report Key: 22136583
• Report Number: 3003753847-2025-00012
• Device Sequence Number: 8526797
• Product Code: IMD
• UDI-Device Identifier: 10885632413735
• UDI-Public: 10885632413735
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025
• Report Date (Section F): 06/03/2025

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: Lay User/Patient
• Device Model Number: 51775
• Device Catalogue Number: 51775
• Device Lot Number: 2408RA75V4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/12/2025
• 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: Female
• Date Report Sent to FDA: 06/03/2025