D
Patient 1
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.
MAUDE MDR 963381
- MDR report key
- 963381
- Report number
- 1820334-2007-00489
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-11-13
- Date received
- 2007-12-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WILLS-OGLESBY GASTROSTOMY CATHETER | EZK- SPECIAL SET | COOK, INC. | EZK | NA | ULT12.0-38-35-P-12 | F2094835 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-12-13 | 0 |
Event Narratives#
N
Patient 1
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.