MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for CENTURION 310CR manufactured by Centurion Medical Products Corporation.
[178568687]
During circumcision: no hemostasis, no closing - clamp removed the foreskin. Centurion was used to circumcise infant by doctor when she closed the clamp, instead of just providing hemostasis, it removed the foreskin from the penis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693510 |
| MDR Report Key | 9693510 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-10-20 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Brand Name | CENTURION |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2020-02-11 |
| Model Number | 310CR |
| Catalog Number | 310CR |
| Lot Number | 2019061801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORPORATION |
| Manufacturer Address | 301 CATRELL DR HOWELL MI 48843 US 48843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |