MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-10 for LATEX GLOVES manufactured by .
[15913787]
Pt was receiving first dose of vancomycin 1gm/200 cc ns iv over 60 min. She began complaints of "itching on the neck. " pt was wearing latex gloves during the procedure and later reported a latex allergy, the drug was dropped and the gloves removed. Ceftriaxone 2gm/100cc ns was then begun. The pt again complained of itching. The drug was stopped and the pt was given benadryl 25 mg po. The pt had no further problems. Diagnosis or reason for use: i and d of index finger.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5039607 |
MDR Report Key | 4341998 |
Date Received | 2014-12-10 |
Date of Report | 2014-12-10 |
Date of Event | 2014-11-18 |
Date Added to Maude | 2014-12-19 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LATEX GLOVES |
Generic Name | LATEX GLOVES |
Product Code | LYY |
Date Received | 2014-12-10 |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-12-10 |