FDA Adverse Event
Other
Summary report: N
GAMMEX PF
MDR report key: 977853
·
Received January 9, 2008
Report
- Report Number
- 1019632-2008-00002
- Event Type
- Other
- Date Received
- January 9, 2008
- Date of Event
- December 20, 2007
- Report Date
- January 9, 2008
- Manufacturer
- ANSELL N.P. SDN. BHD
- Product Code
- KGO
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT FILED IN ANOTHER COUNTRY, HOWEVER, THE SAME OR SIMILAR GLOVE IS SOLD IN THE US.
Description of Event or Problem · 1
THE CUSTOMER CLAIMS THAT THEY HAVE CHANGED FROM PROTIGRITY TO GAMMEX MICROTHIN PF AFTER BURNING DURING. THEN, THE USER HAD A LOCAL SKIN REACTION WHICH BECOME GENERAL: ALLERGY. CUSTOMER HAS CHANGED AGAIN FROM GAMMEX PF MICRO THIN TO TRIFLEX, AND NO MORE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GAMMEX PF | SURGICAL GLOVE | KGO | ANSELL N.P. SDN. BHD | 0707509304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |