MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-24 for UNIVERSAL HOSE, 10 FT 00505201000 manufactured by Conmed.
[106396453]
The reported devices are being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the devices evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[106396454]
The conmed sales representative reported on behalf of the user facility that post open heart surgery, the patient had an infection. During the procedure a 00505201000 universal hose was used. The device was reported to be leaking liquid and gas from where the handpiece was connected to the reported hose. The customer is unsure if the leak contributed to the infection. Although multiple attempts have been made, to date, no additional patient status or procedure information has been made available. This report is raised on the basis of a reported patient infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00056 |
| MDR Report Key | 7456231 |
| Report Source | OTHER |
| Date Received | 2018-04-24 |
| Date of Report | 2018-06-12 |
| Date Mfgr Received | 2018-05-11 |
| Device Manufacturer Date | 2015-02-26 |
| Date Added to Maude | 2018-04-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNIVERSAL HOSE, 10 FT |
| Generic Name | DRILL HOSE, SURGICAL |
| Product Code | BYX |
| Date Received | 2018-04-24 |
| Returned To Mfg | 2018-04-28 |
| Catalog Number | 00505201000 |
| Lot Number | 628834 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-24 |