MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-18 for 8 CHANNEL COLONIC CATHETER manufactured by Medi-plus.
[36883413]
Lower motility catheter defect. Unable to pass guidewire through during procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059547 |
| MDR Report Key | 5384777 |
| Date Received | 2016-01-18 |
| Date of Report | 2016-01-18 |
| Date of Event | 2016-01-12 |
| Date Added to Maude | 2016-01-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 8 CHANNEL COLONIC CATHETER |
| Generic Name | 8 CHANNEL COLONIC CATHETER |
| Product Code | FCX |
| Date Received | 2016-01-18 |
| Lot Number | 1160923 |
| ID Number | 0105055140700772 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDI-PLUS |
| Manufacturer Address | HIGH WYCOMBE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-18 |