MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for CENTURION CIRCLAMP manufactured by Centurion Medical Products.
Report Number | 1824619-2019-00001 |
MDR Report Key | 8890208 |
Date Received | 2019-08-13 |
Date of Report | 2019-08-13 |
Date Mfgr Received | 2019-07-17 |
Date Added to Maude | 2019-08-13 |
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 | MS. KAREN KOWALCZYK |
Manufacturer Street | 100 CENTURION WAY |
Manufacturer City | WILLIAMSTON MI 48895 |
Manufacturer Country | US |
Manufacturer Postal | 48895 |
Manufacturer Phone | 5175451122 |
Manufacturer G1 | CENTURION MEDICAL PRODUCTS |
Manufacturer Street | 301 CATRELL DR |
Manufacturer City | HOWELL MI 48843 |
Manufacturer Country | US |
Manufacturer Postal Code | 48843 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | CENTURION CIRCLAMP |
Generic Name | CIRCUMCISION CLAMP |
Product Code | HFX |
Date Received | 2019-08-13 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CENTURION MEDICAL PRODUCTS |
Manufacturer Address | 100 CENTURION WAY WILLIAMSTON MI 48895 US 48895 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-08-13 |