MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-25 for LATEX FOLEY CATHETER UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[185013112]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be bad fit with shaft/no drainage eye/ poorly seated balloon /bladder neck interface. The lot number is unknown; therefore, the device history record could not be reviewed. Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.
Patient Sequence No: 1, Text Type: N, H10
[185013113]
It was reported that the foley leaked around the meatus. No medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02115 |
| MDR Report Key | 9880962 |
| Report Source | OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-25 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX FOLEY CATHETER |
| Generic Name | UNK FOLEY CATHETER |
| Product Code | EZC |
| Date Received | 2020-03-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |