MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-08-04 for HENRY SCHEIN 1025355 manufactured by Wrp Asia Pacific Sdn. Bhd..
[6640914]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2015-00006 |
| MDR Report Key | 4966058 |
| Report Source | * |
| Date Received | 2015-08-04 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-17 |
| Date Facility Aware | 2015-07-23 |
| Report Date | 2015-08-04 |
| Date Reported to FDA | 2015-08-04 |
| Date Reported to Mfgr | 2015-08-04 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | CRITERION CL GLOVE PF LATEX |
| Product Code | LYY |
| Date Received | 2015-08-04 |
| Catalog Number | 1025355 |
| Lot Number | W406600502 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRP ASIA PACIFIC SDN. BHD. |
| Manufacturer Address | LOT 1, JALAN 3 KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI, SEPANG SELANGOR 43900 MY 43900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-04 |