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.
[1067523]
The patient with history of diverticulitis with enterocolic fistula. She was enrolled onto niti study (b) (4). Surgery on (b) (6) 2008 for laparoscopic sigmoid colectomy repair of fistula. She tolerated the procedure well and was transferred post operatively to the surgical floor. The patient was kept nop since she was complaining of nausea. On pod5, she had abdominal distention, vomiting and fever of 39. 5 c. A ct of the abdomen and pelvis was ordered which shoed a thick walled loculated fluid collection suspicious for abscess. The patient was kept npo and was placed on tpn and appropriate antibiotics she progressed well and on pod 10 a repeat ct scan was done. Which showed a persistent but much smaller abscess fluid collection. The patient remained stable and was advanced to regular diet. She was also having bowel movements. Her symptoms of nausea, vomiting and abdominal distention resolved. She was discharged on pod 12 to home on oral antibiotics and with a plan to repeat ct scan in 2 weeks along with a clinic visit for follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006298502-2008-00002 |
| MDR Report Key | 1327634 |
| Report Source | 99 |
| Date Received | 2008-09-11 |
| Date of Report | 2008-09-11 |
| Date of Event | 2008-06-25 |
| Date Facility Aware | 2008-06-25 |
| Report Date | 2008-09-11 |
| Date Reported to FDA | 2008-07-22 |
| Date Reported to Mfgr | 2008-06-25 |
| Date Added to Maude | 2010-06-12 |
| 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 |
| 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 | NATANYA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-09-11 |