MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for CLAMP, CIRCUMCISION manufactured by Centurion Medical Products Corporation.
[184280118]
Patient a. New born boy had circumcision w/1. 1 with heavy bleeding pedi-cauterized to control. No device retained. Patient b. New born boy had circumcision w/1. 3 cm centurion circlam bell in place but rest of device would not line up. Baby fine. A new device was opened and used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859690 |
| MDR Report Key | 9859690 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-21 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2020-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORPORATION |
| Manufacturer Address | 3310 S MAIN ST SALISBURY NC 28147 US 28147 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |