MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-29 for LEVIN TUBE 15-5710 manufactured by Seamless/div Of Professional Med Prd.
[21386575]
Pt entered the emergency room with severe stomach pains, md requested ng stomach tube be inserted into pt, when the nurse went to confirm placement she realized the tube was defective. The holes were in the wrong end. Nurse removed defective tube and inserted new tube without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011229 |
| MDR Report Key | 87313 |
| Date Received | 1997-04-29 |
| Date of Report | 1997-04-17 |
| Date of Event | 1997-02-19 |
| Date Added to Maude | 1997-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVIN TUBE |
| Generic Name | STOMACH TUBE 12 FR |
| Product Code | FRQ |
| Date Received | 1997-04-29 |
| Model Number | 15-5710 |
| Catalog Number | 15-5710 |
| Lot Number | +H44215571012* |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 86467 |
| Manufacturer | SEAMLESS/DIV OF PROFESSIONAL MED PRD |
| Manufacturer Address | PO BOX 3288 GREENWOOD SC 29648 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-29 |