MAUDE Adverse Event Report: Medline Industries, LP Medline; PACK,COLD,DELUXE,OB-PAD,4.5X14.25

Catalog Number	MDS148055
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer reported, "i was using the baby & me perineal cold pack and it burst.".
Additional Manufacturer Narrative
It was reported that the customer reported, "i was using the baby & me perineal cold pack and it burst." the customer reported, "the chemicals burned my inner thighs and vagina." following the event, the customer reported, "i rinsed my thighs and vagina with water." there were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: PACK,COLD,DELUXE,OB-PAD,4.5X14.25
• Manufacturer (Section D): Medline Industries, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50201410
• Report Number: 1417592-2026-08457
• Device Sequence Number: 18751081
• Product Code: IMD
• UDI-Device Identifier: 00080196733722
• UDI-Public: 00080196733722
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS148055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 145 LB