MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-02 for KENDALL * 145540 manufactured by The Kendall Co..
[167633]
Kendall enema bag used to administer tap water enema prior to colonoscopy. During the procedure rectal abrasions noted at approximately 10 cm. Abrasions noted on prior pts with similar procedures. Enema bag tubing has sharp inner surface on insertion end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019422 |
| MDR Report Key | 288447 |
| Date Received | 2000-08-02 |
| Date of Report | 2000-07-26 |
| Date of Event | 2000-07-26 |
| Date Added to Maude | 2000-08-08 |
| 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 |
| 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 | KENDALL |
| Generic Name | SEAMLESS ENEMA BAG |
| Product Code | FCE |
| Date Received | 2000-08-02 |
| Model Number | * |
| Catalog Number | 145540 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 279139 |
| Manufacturer | THE KENDALL CO. |
| Manufacturer Address | * MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-02 |