MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-22 for CIRC BELL AND INSERT manufactured by Centurion Medical Products Corp..
[1746320]
Surgeon applied gomco and bell to infant and turned the clamp until tight. Surgeon concerned that something did not feel right so rather than make usual incision with the blade, made a small "nick". There was much blood indicating that the clamp had not caused hemostasis at which time surgeon removed the gomco and bell, held pressure until rn could get another 1. 1 bell with a matching 1. 1 ring. New ring placed on gomco and bell applied to infant and procedure completed without incidence. Approx 5 ml of blood loss due to bell (1. 1) not matched with correct ring (package from centurion had a 1. 3 ring in the 1. 1 package).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018685 |
| MDR Report Key | 1938524 |
| Date Received | 2010-12-22 |
| Date of Report | 2010-12-15 |
| Date of Event | 2010-12-08 |
| Date Added to Maude | 2011-01-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CIRC BELL AND INSERT |
| Product Code | FHG |
| Date Received | 2010-12-22 |
| Lot Number | 2010080901 |
| ID Number | REORDER 110CR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP. |
| Manufacturer Address | WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2010-12-22 |