MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-30 for BIODYNAMIX ANASTOMOSIS WITH COLONRING manufactured by Niti Surgical Solutions.
[16838884]
During surgical connection of two ends of colon, a product called the colonring was utilized to maintain anastomosis. Post op day 1 fevers to 104 along with ileus. In 2009, ct indicated concern for anastomotic leak. Ct the following day, confirmed a anastomatic leak and pt returned to surgery. Peritonitis obvious along with leak possibly due to failure of colonring. Repair resulted in colostomy with surgical wound left open for subsequent treatment modalities. Dates of use: 2009. Diagnosis or reason for use: to connect two ends of resected bowel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014188 |
| MDR Report Key | 1571211 |
| Date Received | 2009-12-30 |
| Date of Report | 2009-12-30 |
| Date of Event | 2009-12-16 |
| Date Added to Maude | 2010-01-11 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODYNAMIX ANASTOMOSIS WITH COLONRING |
| Generic Name | CAR 27 |
| Product Code | LNN |
| Date Received | 2009-12-30 |
| Returned To Mfg | 2009-12-29 |
| Lot Number | 43271163 |
| ID Number | CAR 27 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NITI SURGICAL SOLUTIONS |
| Manufacturer Address | CHESTERFIELD MO 63005 US 63005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-12-30 |