MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-07 for TRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG 25067 manufactured by Young Innovations Llc Dba Plak Smacker.
[61654102]
Customer has mentioned that the device will be returned for an evaluation but didn't receive it yet.
Patient Sequence No: 1, Text Type: N, H10
[61654103]
Plak smacker received a complaint saying doctor's hands turned red and itchy when she used plak smaker hand gloves. Doctor didn't receive any medical treatment and her symptoms cleared up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024980-2016-00006 |
| MDR Report Key | 6152447 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS ASMITA PATEL |
| Manufacturer Street | 2260 WENDT ST |
| Manufacturer City | ALGONQUIN IL 60102 |
| Manufacturer Country | US |
| Manufacturer Postal | 60102 |
| Manufacturer Phone | 8474585642 |
| Manufacturer G1 | YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
| Manufacturer Street | 2260 WENDT ST. |
| Manufacturer City | ALGONQUIN IL 60102 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG |
| Generic Name | TRUFIT GRAPE SCENTED NITRILE GLOVES - X-SMALL (100 CT), PS - ALG |
| Product Code | LZA |
| Date Received | 2016-12-07 |
| Catalog Number | 25067 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
| Manufacturer Address | 2260 WENDT ST. ALGONQUIN IL 60102 US 60102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-07 |