MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for HENRY SCHEIN 103-2331 manufactured by Supermax Glove Manufacturing Sdn Bhd.
[78350871]
The dentist reports that after wearing latex gloves he developed a rash on his hands. The dentist decided to go to a dermatologist and was prescribed tetrix cream. The dentist's hands are getting better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2017-00003 |
| MDR Report Key | 6664605 |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-15 |
| Date Facility Aware | 2017-06-05 |
| Report Date | 2017-06-23 |
| Date Reported to FDA | 2017-06-23 |
| Date Reported to Mfgr | 2017-06-23 |
| Date Added to Maude | 2017-06-23 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | DERMATOUCH GLOVE LP LATEX |
| Product Code | LYY |
| Date Received | 2017-06-23 |
| Catalog Number | 103-2331 |
| Lot Number | 6619215220 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUPERMAX GLOVE MANUFACTURING SDN BHD |
| Manufacturer Address | LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA SUNGAI BULOH, SELANGOR 47000 MY 47000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-23 |