MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-03-26 for CONMED IV CONTROLLER MF-12 manufactured by Conmed Corp..
[15006170]
Reported that the unit was dripping in the off position. Iv set up was a straight hang. Nitroglycerin was being infused. No pt incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-1998-00019 |
| MDR Report Key | 159618 |
| Report Source | 05,07 |
| Date Received | 1998-03-26 |
| Date of Report | 1998-02-25 |
| Date of Event | 1998-02-25 |
| Date Facility Aware | 1998-02-25 |
| Report Date | 1998-02-25 |
| Date Mfgr Received | 1998-02-25 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1998-03-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED IV CONTROLLER |
| Generic Name | IV CONTROLLER |
| Product Code | LDR |
| Date Received | 1998-03-26 |
| Model Number | NA |
| Catalog Number | MF-12 |
| Lot Number | 36151 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155461 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST. UTICA NY 13501 US |
| Baseline Brand Name | CONMED IV CONTROLLER |
| Baseline Generic Name | IV CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | MF-12 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-26 |