FDA Adverse Event
Malfunction
Summary report: N
STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK
MDR report key: 11789897
·
Received May 6, 2021
Report
- Report Number
- MW5101219
- Event Type
- Malfunction
- Date Received
- May 6, 2021
- Date of Event
- April 27, 2021
- Report Date
- May 4, 2021
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- OJH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CUT IN STERILE TABLE COVER. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683366 | STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK | ORTHOPEDIC TRAY | OJH | MEDLINE INDUSTRIES, INC. | 20HB0550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |