MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-12 for CHESTER LABS -GENT-1-TIP 101503 manufactured by Chester Labs.
[764644]
Enema gave causing sharp retal pain. When removed piece of tip fell on to pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004661 |
| MDR Report Key | 963793 |
| Date Received | 2007-12-12 |
| Date of Report | 2007-11-16 |
| Date of Event | 2007-09-27 |
| Date Added to Maude | 2007-12-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHESTER LABS -GENT-1-TIP |
| Generic Name | ENEMA |
| Product Code | FCE |
| Date Received | 2007-12-12 |
| Returned To Mfg | 2007-11-15 |
| Catalog Number | 101503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 936855 |
| Manufacturer | CHESTER LABS |
| Manufacturer Address | 1900 SECTION RD CINCINNATI OH 45237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-12 |