MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-07 for CLEAR-THERM 3 HMEF 1541000 manufactured by Intersurgical Limited Guernsey.
| Report Number | 1319447-2019-00002 |
| MDR Report Key | 9292786 |
| Date Received | 2019-11-07 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-10-04 |
| Date Added to Maude | 2019-11-07 |
| 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 | MR. IVAN SENIUT |
| Manufacturer Street | ARNIONIU 60/28-1 |
| Manufacturer City | PABRADE, VILNIAUS APSKRITIS, LT-4710 |
| Manufacturer Country | LH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR-THERM 3 HMEF |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2019-11-07 |
| Model Number | 1541000 |
| Lot Number | 2191371 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSURGICAL LIMITED GUERNSEY |
| Manufacturer Address | CIRCUIT HOUSE, PITRONNERIE RD ST. PETER PORT, GUERNSEY CHANNEL ISLANDS GY12RL UK GY12RL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-07 |