MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-17 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100510190 manufactured by Unomedical Ltd..
[21545874]
The nurse reports scarce urine drainage from the patient even after doses of diuretics administered per medication schedule. It is further reported 'in the following hours 300 cubic centimeters' of urine was obtained and patient was diagnosed with urinary retention. The nurse adds on (b)(6), 2015 the following urine output from the patient was obtained: at eighteen hours 70cc, at twenty hours 30cc at which time 10 mg of furosemide was administered 'in accordance to the schedule', at twenty-two hours 35cc, at twenty-four hours 20cc. The nurse adds at 02 am on (b)(6) 2015 the patient had 90 cc urine output and received 10mg of furosemide 'as scheduled'. The urine output at 04 am on (b)(6) 2015 was 300cc, at 06 am 200cc and on the 'day shift of (b)(6) 2015 there are no variabilities reported in relation to the diuresis data'. The nurse adds the unometer safeti plus was in place for thirteen days.
Patient Sequence No: 1, Text Type: D, B5
[21697873]
Based on the available information, this event is deemed to be a serious injury. No further information was available at the time of the report. Additional patient/event details have been requested. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[31350584]
A quality complaint investigation was performed. A complaint sample was not received to assist with the investigation. After a detailed batch review, no discrepancies related to complaint issue were found. A previous investigation is applicable to this complaint. This previous investigation is closed. Therefore, this complaint will be closed without further action. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00064 |
| MDR Report Key | 4927651 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-08-19 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-07-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Manufacturer G1 | CONVATEC |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-07-17 |
| Model Number | 158100510190 |
| Lot Number | 654400 |
| Device Expiration Date | 2018-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION, MINSKAYA VOBLASTS BO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-17 |