MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2007-12-13 for WILLS-OGLESBY GASTROSTOMY CATHETER ULT12.0-38-35-P-12 manufactured by Cook, Inc..
[761371]
Info was provided that the physician experienced great difficulty in removing the tube from the pt, requiring increased amounts of analgesia to the pt. Upon removal, it was noted that the tube had tied itself into a knot.
Patient Sequence No: 1, Text Type: D, B5
[8090206]
Evaluation: no product was returned to assist in our investigation, however, photos were provided, which showed the tubing has knotted. Based on the info provided and the condition of the device in the photo images, it is feasible to say the knot formed during placement, as the result of pt anatomy or possible pt intervention. It should be noted this is a soft, pliable tubing designed for pt comfort, that can be manipulated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2007-00489 |
| MDR Report Key | 963381 |
| Report Source | 01,05,08 |
| Date Received | 2007-12-13 |
| Date of Report | 2007-11-14 |
| Date of Event | 2007-11-13 |
| Date Facility Aware | 2007-11-13 |
| Report Date | 2007-11-14 |
| Date Mfgr Received | 2007-11-14 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-03-26 |
| 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 | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLS-OGLESBY GASTROSTOMY CATHETER |
| Generic Name | EZK- SPECIAL SET |
| Product Code | EZK |
| Date Received | 2007-12-13 |
| Model Number | NA |
| Catalog Number | ULT12.0-38-35-P-12 |
| Lot Number | F2094835 |
| Device Expiration Date | 2010-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 968843 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-13 |