MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-08-21 for manufactured by .

Event Text Entries

[25282974] (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[37344261] Corrective/preventive action plan: no corrective action is initiated at this point of time as the product conforms to the requirement and the allergy could be individual specific. Conclusion: we have also logged this complaint into our database system and will closely monitor our product performance to meet the quality objectives.
Patient Sequence No: 1, Text Type: N, H10


[37344263] The doctor had an allergic reaction to the gloves which resulted in needing to go to the emergency room. The doctor's left hand was swollen and had to take antibiotics for about a week. We have been unable to obtain any additional information regarding treatment after several attempts. Quantity returned: one dispenser.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8041005-2015-00001
MDR Report Key5060316
Report Source08
Date Received2015-08-21
Date Mfgr Received2015-08-05
Device Manufacturer Date2014-06-01
Date Added to Maude2015-09-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSARALA JAYARMAN
Manufacturer StreetLOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI
Manufacturer CitySEPANG, SELANGOR DARUL EHSAN 43900
Manufacturer CountryMY
Manufacturer Postal43900
Manufacturer Phone87061486
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Product CodeLYY
Date Received2015-08-21
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.