MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-27 for CENTURION CIRCLAMP 310CR manufactured by Centurion Medical Products.
[177338561]
A recall associated with this lot had already been initiated prior to the receipt of this complaint. Our records indicate the user was notified on 8/28/2019 and the user subsequently reported they had no inventory remaining from this lot on (b)(6) 2019. Per the complaint report, the device associated with this report was used in (b)(6) 2019.
Patient Sequence No: 1, Text Type: N, H10
[177338562]
Circlamp removed foreskin without the use of scalpel, required sutures to stop bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824619-2020-00001 |
| MDR Report Key | 9633164 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2020-01-27 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3008403546-08-26-2019/01 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION CIRCLAMP |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2020-01-27 |
| Model Number | 310CR |
| Lot Number | 2019061801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-27 |