MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-23 for FLEXISEAL * manufactured by Convatec, A Bristo-myers Squibb Co..
[20023839]
High white blood count and loose stools with negative c-diff assay. Rectal tube placed to try to manage stooling. The patient's hematocrit dropped to 24 (from 39) in setting of anticoagulation and intra aortic balloon pump (iabp); gastroenterology did colonoscopy at bedside - identified ulceration and mucosal friability at rectal tube balloon. Anticoagulation and rectal tube discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 891315 |
| MDR Report Key | 891315 |
| Date Received | 2007-07-23 |
| Date of Report | 2007-07-23 |
| Date of Event | 2007-05-11 |
| Report Date | 2007-07-23 |
| Date Reported to FDA | 2007-07-23 |
| Date Added to Maude | 2007-08-09 |
| 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 | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | FLEXISEAL |
| Generic Name | TUBE, RECTAL |
| Product Code | GBT |
| Date Received | 2007-07-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 868558 |
| Manufacturer | CONVATEC, A BRISTO-MYERS SQUIBB CO. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2007-07-23 |