MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-08 for ROSS LABS FLEXIFLO #20 UNKNOWN manufactured by Ross Laboratories.
[18831372]
Internal bumper from a p. E. G. Tube placed 7/29/94 became seperated from external tube. Required endoscopic removal. According to care givers, pt pulled on external tube causing the seperation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24867 |
| MDR Report Key | 24867 |
| Date Received | 1995-03-08 |
| Date of Report | 1995-01-30 |
| Date of Event | 1994-08-18 |
| Date Facility Aware | 1994-08-18 |
| Report Date | 1995-01-30 |
| Date Reported to Mfgr | 1994-08-19 |
| Date Added to Maude | 1995-08-23 |
| 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 | ROSS LABS |
| Generic Name | FLEXIFLO #20 PEG TUBE & BUMPER |
| Product Code | FFW |
| Date Received | 1995-03-08 |
| Model Number | FLEXIFLO #20 |
| Catalog Number | UNKNOWN |
| Lot Number | NA |
| ID Number | UNKNOWN |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25289 |
| Manufacturer | ROSS LABORATORIES |
| Manufacturer Address | COLUMBUS OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-03-08 |