MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-29 for KENDALL ENEMA BAG * 145540 manufactured by Tyco Healthcare/kendall.
[430323]
A customer had a problem with an enema bag with tubing. Sustained a rectal perforation during ct scan of abdomen & pelvic requiring insertion of rectal tube for admin of rectal contrast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2005-00024 |
| MDR Report Key | 646550 |
| Report Source | 05 |
| Date Received | 2005-09-29 |
| Date of Report | 2005-09-29 |
| Date of Event | 2005-08-12 |
| Date Mfgr Received | 2005-09-29 |
| Date Added to Maude | 2005-11-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ESIE CABRAL |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | KENMEX |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA SUITE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL ENEMA BAG |
| Generic Name | ENEMA BAG WITH TUBING |
| Product Code | FCE |
| Date Received | 2005-09-29 |
| Model Number | * |
| Catalog Number | 145540 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 636057 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Baseline Brand Name | KENDALL ENEMA BAG |
| Baseline Generic Name | ENEMA BAG WITH TUBING |
| Baseline Model No | * |
| Baseline Catalog No | 145540 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-29 |