MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-26 for DEROYAL 81-080410 manufactured by Deroyal Industries, Inc..
[4343621]
The hospital reported that the foley was inserted on (b)(6) 2014, and then irrigated and changed on (b)(6) 2014. When this occurred there was bleeding from the urethra and they were unable to place another foley. A feeding tube had to be inserted.
Patient Sequence No: 1, Text Type: D, B5
[11568798]
Deroyal: the reported device is not available for evaluation. Investigation into the root cause is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320762-2014-00005 |
| MDR Report Key | 3672074 |
| Report Source | 06 |
| Date Received | 2014-02-26 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-10 |
| Date Facility Aware | 2014-01-10 |
| Report Date | 2014-01-31 |
| Date Reported to Mfgr | 2014-01-31 |
| Date Mfgr Received | 2014-01-31 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-03-12 |
| 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 | COURTNEY RINEHART |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2014-02-26 |
| Catalog Number | 81-080410 |
| Lot Number | 34418077 |
| Device Expiration Date | 2018-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | NEW TAZEWELL TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-26 |