MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-19 for TELETOM TEL00000001 manufactured by Stryker-communications.
| Report Number | 0002031963-2019-00005 |
| MDR Report Key | 9343794 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-19 |
| 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. KIMBERLY LYNCH |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer Phone | 9724107100 |
| Manufacturer G1 | STRYKER-COMMUNICATIONS |
| Manufacturer Street | 1410 LAKESIDE PARKWAY #100 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELETOM |
| Generic Name | BOOM |
| Product Code | FQO |
| Date Received | 2019-11-19 |
| Catalog Number | TEL00000001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER-COMMUNICATIONS |
| Manufacturer Address | 1410 LAKESIDE PARKWAY #100 FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-19 |