MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-09-11 for COMPRESSION ANASTOMOSIS RING 435110-27 manufactured by Niti Surgical Solutions Ltd.
[1031794]
Anastomotic leak - on day 5 after surgery, the patient felt bad. Prof. Decided to reoperate her. After he opened her, and got to the anastomosis the proximal colon was fully opened. He cut the ring and performed hartmann colostoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006298502-2008-00003 |
| MDR Report Key | 1327633 |
| Report Source | 99 |
| Date Received | 2008-09-11 |
| Date of Report | 2008-09-11 |
| Date of Event | 2008-06-29 |
| Date Facility Aware | 2008-06-29 |
| Report Date | 2008-09-11 |
| Date Reported to FDA | 2008-07-29 |
| Date Reported to Mfgr | 2008-06-29 |
| Date Added to Maude | 2009-11-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSION ANASTOMOSIS RING |
| Generic Name | CAR 27 |
| Product Code | LNN |
| Date Received | 2008-09-11 |
| Catalog Number | 435110-27 |
| Lot Number | 43271101 |
| ID Number | REF EC 27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NITI SURGICAL SOLUTIONS LTD |
| Manufacturer Address | NETANYA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-09-11 |