MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-21 for CADD ACCESSORIES 21-2186-25 manufactured by Smiths Medical Asd, Inc.
[145745459]
Information was received indicating that the cord gets disconnected when the button is pressed on a smiths cadd accessories. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02474 |
| MDR Report Key | 8629706 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-21 |
| Date of Report | 2019-11-18 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-05-21 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPLOIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD ACCESSORIES |
| Generic Name | CADD ACCESSORIES |
| Product Code | MRZ |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-17 |
| Catalog Number | 21-2186-25 |
| Lot Number | 0095250-4-1 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |