MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-14 for HENRY SCHEIN INC. 112-5532 manufactured by Kossan Latex Industries (m) Sdn. Bhd..
| Report Number | 3005632797-2019-00001 |
| MDR Report Key | 8710399 |
| Date Received | 2019-06-14 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-04-30 |
| Date Facility Aware | 2019-04-03 |
| Report Date | 2019-04-25 |
| Date Reported to FDA | 2019-04-25 |
| Date Reported to Mfgr | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-06-18 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YEN MUN AU |
| Manufacturer Street | LOT 6129, JALAN HAJI ABDUL MANAN, BT 5 1/4, OFF JLN MERU |
| Manufacturer City | KLANG, |
| Manufacturer G1 | KOSSAN LATEX INDUSTRIES (M) SDN BHD |
| Manufacturer Street | LOT 6129, JALAN HAJI ABDUL MANAN, BT 5 1/4, OFF JLN MERU |
| Manufacturer City | KLANG, 41050 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 41050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HENRY SCHEIN INC. |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2019-06-14 |
| Catalog Number | 112-5532 |
| Lot Number | K10048407 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
| Manufacturer Address | LOT 6129, JALAN HAJI ABDUL MANAN, BATU 5 1/4 OFF JLN MERU KLANG, SELANGOR 41050 MY 41050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-14 |