MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-16 for TRANSVAGINAL 3.0 MM INTRODUCER CAL-TV30 manufactured by Caldera Medical Inc..
| Report Number | 3003990090-2019-01485 |
| MDR Report Key | 8902334 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-16 |
| Date of Report | 2019-10-29 |
| Date Mfgr Received | 2019-07-18 |
| Date Added to Maude | 2019-08-16 |
| 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. IEVA SIROKOVIENE |
| Manufacturer Street | 5171 CLARETON DRIVE |
| Manufacturer City | AGOURA HILLS CA 91301 |
| Manufacturer Country | US |
| Manufacturer Postal | 91301 |
| Manufacturer Phone | 8184837641 |
| Manufacturer G1 | CALDERA MEDICAL INC. |
| Manufacturer Street | 5171 CLARETON DRIVE |
| Manufacturer City | AGOURA HILLS CA 91301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSVAGINAL 3.0 MM INTRODUCER |
| Generic Name | TRANSVAGINAL INTRODUCER |
| Product Code | PWJ |
| Date Received | 2019-08-16 |
| Returned To Mfg | 2019-08-21 |
| Catalog Number | CAL-TV30 |
| Lot Number | 46594 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CALDERA MEDICAL INC. |
| Manufacturer Address | 5171 CLARETON DRIVE AGOURA HILL CA 91301 US 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-08-16 |