MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-31 for FLEET BAGENEMA 30132090110 8 manufactured by C.b. Fleet Co, Inc..
[17827812]
End of rectal tube is not cut eveny or smoothly. Pts fear injury to rectum. Contacted co 8/95, returned product 10/95. Second pt's date of birth 12/28/00, weight 150.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009218 |
| MDR Report Key | 33284 |
| Date Received | 1996-05-31 |
| Date of Report | 1996-05-20 |
| Date Added to Maude | 1996-06-05 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | FLEET BAGENEMA |
| Generic Name | DISPOSABLE ENEMA SET |
| Product Code | FCE |
| Date Received | 1996-05-31 |
| Model Number | 30132090110 8 |
| Lot Number | BEZ021, BWEZ020, BEZ019 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34605 |
| Manufacturer | C.B. FLEET CO, INC. |
| Manufacturer Address | PO BOX 11349 LYNCHBURG VA 24506 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-31 |