FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 23838918
·
Received December 18, 2025
Report
- Report Number
- 2411236-2025-00004
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- December 6, 2025
- Report Date
- December 19, 2025
- Manufacturer
- JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
- Product Code
- IMD
- UDI-DI
- 00304040037072
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A MALE PATIENT REPORTS THAT HE APPLIED THE DISPOSABLE INSTANT COLD COMPRESS WRAPPED IN A TOWEL OVER HIS TEE SHIRT FOR A BACKACHE. THE DISPOSABLE INSTANT COLD COMPRESS WAS APPLIED TO THE AREA FOR 20 MINUTES. THE PATIENT SUSTAINED SECOND DEGREE BURNS AND BURSTING BLISTERS. THE PATIENT CLAIMS THAT THE BURNS WERE THE SIZE OF THE DISPOSABLE INSTANT COLD COMPRESS. THE PATIENT IS UNDERGOING TREATMENT AS A RESULT.
Description of Event or Problem · 0
THIS REPORT PROVIDES ADDITIONAL INFORMATION FOR THE INCIDENT INITIALLY REPORTED ON (B)(6) 2025. THE REPORTER STATED THAT THE INSTANT COLD COMPRESS HAD BEEN STORED IN THE FREEZER AND WAS REMOVED PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2386729 | HENRY SCHEIN | COLD COMPRESS INSTANT DISPOSABLE | IMD | JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. | 025HSN31002 | 00304040037072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |