MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-06-13 for EASI-LAV WITH CHAR-FLO 15341 manufactured by Ballard Medical Products.
[207276]
Report from user facility stated that during a gastric lavage procedure, the gastric tube looped in the esophagus. Perforation of the anterior esophagus portion suspected, but unconfirmed. Patient was transferred to a trauma center. Versed was used and the tube came out easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3031042-2001-00031 |
| MDR Report Key | 337861 |
| Report Source | 05,06 |
| Date Received | 2001-06-13 |
| Date of Report | 2000-01-28 |
| Date of Event | 2000-01-21 |
| Date Mfgr Received | 2001-01-28 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 2001-06-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SALLY HERRICK |
| Manufacturer Street | 12050 LONE PEAK PARKWAY |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8015235105 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASI-LAV WITH CHAR-FLO |
| Generic Name | STOMACH PUMP |
| Product Code | KDH |
| Date Received | 2001-06-13 |
| Model Number | NA |
| Catalog Number | 15341 |
| Lot Number | 80063 |
| ID Number | * |
| Device Expiration Date | 2002-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 327165 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | 12050 LONE PEAK PARKWAY DRAPER UT 84020 US |
| Baseline Brand Name | EASI-LAV WITH CHAR-FLO |
| Baseline Generic Name | STOMACH PUMP |
| Baseline Model No | NA |
| Baseline Catalog No | 15341 |
| Baseline ID | IRRIGATION & AS |
| Baseline Device Family | EASI-LAV |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951533 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-06-13 |