MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-15 for ERASE CAUDI * DYND160116 manufactured by Medline Industries, Inc.
[3998070]
Foley catheter would not inflate - physician had to cut catheter and very slowly deflated. ====================== manufacturer response for foley catheter, foley catheter tray (per site reporter). ====================== thank you for bringing this to our attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3513835 |
| MDR Report Key | 3513835 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-11-15 |
| Date of Event | 2013-11-14 |
| Report Date | 2013-11-15 |
| Date Reported to FDA | 2013-11-15 |
| Date Reported to Mfgr | 2013-12-11 |
| Date Added to Maude | 2013-12-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERASE CAUDI |
| Generic Name | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2013-11-15 |
| Model Number | * |
| Catalog Number | DYND160116 |
| Lot Number | 13IB4058 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-15 |