MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-15 for UNKNOWN PRODUCT-MED manufactured by Sgp01 Singapore.
| Report Number | 1423537-2019-00332 |
| MDR Report Key | 8788923 |
| Date Received | 2019-07-15 |
| Date of Report | 2019-07-15 |
| Date of Event | 2018-02-25 |
| Date Mfgr Received | 2019-06-19 |
| Date Added to Maude | 2019-07-15 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | SGP01 SINGAPORE |
| Manufacturer Street | 10 KALLANG AVENUE , #10-10/18 |
| Manufacturer City | SINGAPORE 339510 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN PRODUCT-MED |
| Generic Name | PATIENT EXAMINATION GLOVE, SPECIALTY |
| Product Code | LZC |
| Date Received | 2019-07-15 |
| Model Number | UNKNOWN PRODUCT-MED |
| Catalog Number | UNKNOWN PRODUCT-MED |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SGP01 SINGAPORE |
| Manufacturer Address | 10 KALLANG AVENUE , #10-10/18 SINGAPORE 339510 SN 339510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-15 |