MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-10-28 for JIMMY JOHN III 2-C * manufactured by Colon Therapeutics Inc..
[19155145]
Claim of an unspecified alleged colon perforation the end user claims to have received at an user facility. Manufacturer investigation into the alleged claim, discovered device did not malfunction, is still operational and continues to operate as intended and designed, with no further report of incidence. Device in question was not returned to manufacturer. Manufacturer has requested more information into the alleged perforation and evidence into the alleged perforation being caused by the colonic device, but to date none has been provided such as type of colon scope used, actual medical history of the user, medical reports of alleged perforation and cause, etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640200-2003-00003 |
| MDR Report Key | 493975 |
| Report Source | 00 |
| Date Received | 2003-10-28 |
| Date of Report | 2003-10-28 |
| Date of Event | 2001-12-13 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2003-11-07 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2909 MAIN AVE |
| Manufacturer City | GROVES TX 77619 |
| Manufacturer Country | US |
| Manufacturer Postal | 77619 |
| Manufacturer Phone | 4099630300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JIMMY JOHN III |
| Generic Name | COLONIC ENEMA DEVICE |
| Product Code | KPL |
| Date Received | 2003-10-28 |
| Model Number | 2-C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 482684 |
| Manufacturer | COLON THERAPEUTICS INC. |
| Manufacturer Address | 2909 MAIN AVE. GROVES TX 77619 US |
| Baseline Brand Name | JIMMY JOHN III |
| Baseline Generic Name | COLON IRRIGATION EQUIPMENT |
| Baseline Model No | 2-C |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | JIMMY JOHN III |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K842083 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2003-10-28 |