MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other report with the FDA on 2019-03-28 for UNKNOWN manufactured by Cook Inc.
[140215856]
Common device name & product code = unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[140215877]
It was reported in the pediatric nephrology journal dated 07feb2003 that a patient developed a small bowel herniation and gangrene after the removal of a 9. 5 french tenckhoff neonatal peritoneal dialysis catheter. The seldinger technique was used to place the tenckhoff catheter on the left side of the abdomen. After 5 days, the patient's renal function improved, the catheter was removed. On the following day (6th day post-placement), a 10 cm-segment of cyanotic small intestine was noted to protrude from the catheter exit site. The patient was diagnosed with incarcerated small bowel and was taken to surgery 90 minutes later. A resection of the small bowel that was not viable was performed. Histopathology confirmed gangrenous changes in the portion of the bowel that was removed. The patient was then transferred back to the pediatric cardio-thoracic team with recommendation to close the ileostomy after further cardiac surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00757 |
| MDR Report Key | 8461266 |
| Report Source | FOREIGN,LITERATURE,OTHER |
| Date Received | 2019-03-28 |
| Date of Report | 2019-08-09 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2019-07-25 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | FKO |
| Date Received | 2019-03-28 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-03-28 |