MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-08-11 for KENDALL SEAMLESS ENEMA BAG manufactured by Tyco Healthcare Group.
[2466701]
Instructions inadequate. Fail to state blue piece must be removed before insertion of tubing in pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2423463 |
| MDR Report Key | 2423463 |
| Report Source | 99 |
| Date Received | 2011-08-11 |
| Date of Report | 2011-08-09 |
| Date of Event | 2011-08-09 |
| Date Facility Aware | 2011-08-09 |
| Report Date | 2011-08-09 |
| Date Reported to FDA | 2011-08-09 |
| Date Reported to Mfgr | 2011-08-09 |
| Date Added to Maude | 2012-01-23 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL SEAMLESS ENEMA BAG |
| Generic Name | ENEMA BAG |
| Product Code | FCE |
| Date Received | 2011-08-11 |
| Lot Number | 106682264 |
| ID Number | REF:145540 |
| Device Expiration Date | 2012-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE GROUP |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02760 US 02760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-11 |