MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-29 for EASI-LAV * manufactured by Kimberly-clark Corporation.
[431506]
The patient was having a bedside egd. The scope and gastric tube were in place. They tried to pull on the pump device and it would not pull in and out. It was like it was off track. A new kit was opened and the pump device worked without problems. The gastric tube remained in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 653482 |
| MDR Report Key | 653482 |
| Date Received | 2005-11-29 |
| Date of Report | 2005-11-29 |
| Date of Event | 2005-11-21 |
| Report Date | 2005-11-29 |
| Date Reported to FDA | 2005-11-29 |
| Date Added to Maude | 2005-12-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASI-LAV |
| Generic Name | ADULT GASTRIC LAVAGE SYSTEM |
| Product Code | KDH |
| Date Received | 2005-11-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 274262 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 15 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 642947 |
| Manufacturer | KIMBERLY-CLARK CORPORATION |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD ROSWELL GA 30076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-29 |