MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-16 for CONVATEC manufactured by Convatec.
[18241665]
Pt had a flexiseal placed in 2009. To ltac at approx 2 weeks later. Readmitted to icu about 2 days later for low grade gi bleed. Pt on heparin gtt and balloon had 60 ml in reservoir. Diagnosis: diarrhea. Event abated after use: yes. Inserted in 2009. D/c/ at approximately 21 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010364 |
| MDR Report Key | 1345984 |
| Date Received | 2009-03-16 |
| Date of Report | 2009-03-16 |
| Date of Event | 2009-02-24 |
| Date Added to Maude | 2009-05-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVATEC |
| Generic Name | FLEXISEAL |
| Product Code | GBT |
| Date Received | 2009-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-03-16 |