MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-06 for FOLEY CATHETER KIT DYND160416 manufactured by Medline Industries, Inc..
[3547882]
Hematuria and discomfort were reported following a catheter insertion.
Patient Sequence No: 1, Text Type: D, B5
[10816303]
A urologist reported hematuria and an increase in patient discomfort following catheter insertions. He attributed the incident to the catheter starting the catheters were more rigid than the catheters they had previously been using. No medical intervention was indicated as a result of the incidents. No sample was returned for evaluation and no lot number was provided. We have received no other similar complaints for this device. A root cause has not been determined and we cannot rule out user technique as a contributing factor. We have not confirmed the issue but in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00051 |
| MDR Report Key | 3170383 |
| Report Source | 05,06 |
| Date Received | 2013-06-06 |
| Date of Report | 2013-06-06 |
| Date Mfgr Received | 2013-05-16 |
| Date Added to Maude | 2013-06-17 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER KIT |
| Product Code | NWR |
| Date Received | 2013-06-06 |
| Catalog Number | DYND160416 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-06 |