MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-30 for COMPRESSION ANASTOMATIC RING CAR27 manufactured by Niti Surgical Solutions.
[1162027]
In 2009, pt underwent sigmoid colectomy for newly diagnosed colon cancer. Compression anastomosis ring inserted at that time. Two days later, discharged home without complications. At about 3 days later, presented to ed with c/o of "constipation and full bladder" and was admitted to hospital. Abdomen distended and tender - ct showed fluid in abdomen. In the same day, returned to or for acute surgical abdomen and possible anastomotic leak. Underwent diagnostic and exploratory laparostomy and colostomy, compression ring removed at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011691 |
| MDR Report Key | 1408672 |
| Date Received | 2009-06-30 |
| Date of Report | 2009-06-24 |
| Date of Event | 2009-05-31 |
| Date Added to Maude | 2009-07-09 |
| 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 | 0 |
| 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 |
| Brand Name | COMPRESSION ANASTOMATIC RING |
| Generic Name | CAR 27 RING |
| Product Code | LNN |
| Date Received | 2009-06-30 |
| Model Number | CAR27 |
| ID Number | 27MM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NITI SURGICAL SOLUTIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-30 |