MAUDE report

MAUDE report 6176: SMARTPRACTICE ECONOMY EXAMINATION GLOVES

Injury · received Jun 25, 1993 · TOMARC (M) SDN. BHD.

Key facts

MDR report key 6176
Report number 2083595-1993-00001
Event type Injury
Brand name SMARTPRACTICE ECONOMY EXAMINATION GLOVES
Catalog number 40-677
Manufacturer TOMARC (M) SDN. BHD.
Product code LYY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jun 25, 1993
Report date May 13, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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