FDA Adverse Event
Malfunction
Summary report: N
ACUPUNCTURE NEEDLE
MDR report key: 234711
·
Received August 4, 1999
Report
- Report Number
- MW1016875
- Event Type
- Malfunction
- Date Received
- August 4, 1999
- Report Date
- July 21, 1999
- Manufacturer
- TCM SUPPLY CORP.
- Product Code
- MQX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BUSINESS SELLS, ACCORDING TO THEIR BROCHURE, "NON-STERILE, REUSABLE" ACUPUNCTURE NEEDLES. SOME NEEDLE LENGTHS RANGE FROM 15CM TO 37CM, LONG ENOUGH TO PENETRATE INTERNAL HUMAN ORGANS. "IS ABOVE MENTIONED ESTABLISHMENT AND DEVICE REGISTERED WITH FDA?"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUPUNCTURE NEEDLE | ACUPUNCTURE NEEDLE | MQX | TCM SUPPLY CORP. | ACUPUNCTURE NEEDLES | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |