FDA Adverse Event
Malfunction
Summary report: N
MEDLINE INDUSTRIES, INC.
MDR report key: 19709996
·
Received July 10, 2024
Report
- Report Number
- 19709996
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Date of Event
- April 1, 2024
- Report Date
- April 17, 2024
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- LRO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PREMIUM DRY TRAY - HAIR IN STERILE PACKAGING WHEN OPENED BY REGISTERED NURSE (RN). MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). MEDLINE SENT SHIPPING LABEL TO RETURN THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447498 | MEDLINE INDUSTRIES, INC. | GENERAL SURGERY TRAY | LRO | MEDLINE INDUSTRIES, INC. | DYND70661 | 11023090358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |