FDA Adverse Event
Malfunction
Summary report: N
OPERATING ROOM TOWELS/SURGICAL TOWELS
MDR report key: 1301969
·
Received February 2, 2009
Report
- Report Number
- MW5009803
- Event Type
- Malfunction
- Date Received
- February 2, 2009
- Report Date
- January 17, 2009
- Manufacturer
- JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. LTD.
- Product Code
- KKX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OUR LAB DATA REVEALS THAT THE OPERATING ROOM TOWELS (ALSO KNOWN AS SURGICAL TOWELS) MANUFACTURED BY JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO (ARE FIERCELY CONTAMINATED WITH MOLDS, SUCH AS PYRONEMA DOMESTICUM, DEINOCOCCUS PROTEOLYTICUS AND DEINOCOCCUS RADIODURANS. PLUS, THE BIOBURDEN LEVEL OF THESE TOWELS IS EXTREMELY HIGH. THE TWO MAIN COMPANIES IMPORTING THESE TOWELS INTO THE STATES ARE MEDLINE INDUSTRIES AND AMD-RITMED. PLEASE STOP THESE TOWELS AND PROTECT THE AMERICANS!
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERATING ROOM TOWELS/SURGICAL TOWELS | KKX | JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |