MAUDE MDR 234711

MDR report key
234711
Report number
MW1016875
Event key
0
Event type
3
Date received
1999-08-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACUPUNCTURE NEEDLEACUPUNCTURE NEEDLETCM SUPPLY CORP.MQXACUPUNCTURE NEEDLES**NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-08-0401. O

Event Narratives#

D

Patient 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?"