| Report Number | 3009613036-2019-00004 |
| MDR Report Key | 9392241 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-30 |
| Date of Report | 2019-11-30 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-11-08 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-11-30 |
| 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 | MR. NARENDRA PATEL |
| Manufacturer Street | SURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG |
| Manufacturer City | CHALA, VAPI, GUJARAT 396191 |
| Manufacturer Country | IN |
| Manufacturer Postal | 396191 |
| Manufacturer G1 | MERIL LIFE SCIENCES PRIVATE LIMITED |
| Manufacturer Street | SURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG |
| Manufacturer City | CHALA, VAPI, 396191 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 396191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |