MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-28 for GLV EXAM NITRILE FLEXAL FEEL PF SM 88TT21S manufactured by Sgp01 Singapore.
| Report Number | 1423537-2019-00375 |
| MDR Report Key | 9390482 |
| Date Received | 2019-11-28 |
| Date of Report | 2019-11-28 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-10-31 |
| Date Added to Maude | 2019-11-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DR |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8878474151 |
| 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 | GLV EXAM NITRILE FLEXAL FEEL PF SM |
| Generic Name | PATIENT EXAMINATION GLOVE |
| Product Code | FMC |
| Date Received | 2019-11-28 |
| Model Number | 88TT21S |
| Catalog Number | 88TT21S |
| Lot Number | 11K19J007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-28 |