FDA Adverse Event
Malfunction
Summary report: N
MEDLINE INDUSTRIES, INC.
MDR report key: 11633767
·
Received April 8, 2021
Report
- Report Number
- 11633767
- Event Type
- Malfunction
- Date Received
- April 8, 2021
- Date of Event
- October 26, 2020
- Report Date
- March 23, 2021
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- OJH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
BACK TABLE PACK OPENED AND FOUND TO HAVE CONCERNS WITH MOLD IN THE FOLDS OF THE PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535368 | MEDLINE INDUSTRIES, INC. | ORTHOPEDIC TRAY | OJH | MEDLINE INDUSTRIES, INC. | DYNJ04385U | 20EKB413 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |