MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for CIRCLAMP manufactured by Centurion Medical Products Corporation.
[178579735]
Circ bell was tightened and the foreskin was almost completely cut off d/t sharpness of the instrument. Premie baby boy 3 weeks early. Chart review indicates no subsequent concerns r/t circumcision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693540 |
| MDR Report Key | 9693540 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-08-01 |
| 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 | CIRCLAMP |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2020-02-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2020-02-11 |