MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-02-19 for URINARY DRAINAGE BAGS 38 155 1S manufactured by Unomedical S.r.o..
[4538970]
Complainant reported pt developing urinary retention as urine unable to flow through tubing into bag at connection site at top of bag. The product was in use for 12-18 hours.
Patient Sequence No: 1, Text Type: D, B5
[12102389]
Based on the info provided this event is deemed a reportable malfunction. It was reported that the pt developed a urinary tract infection. No add'l event/pt details have been provided to date. Should a sample or add'l info become available, a f/u report will be submitted. Reported to the fda on (b)(4) 2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00006 |
| MDR Report Key | 3894328 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-01-24 |
| Date of Event | 2014-01-21 |
| Date Mfgr Received | 2014-01-24 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2014-07-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOC DIR |
| Manufacturer Street | 200 HEADQUARTERS PK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAGS |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION |
| Product Code | FCN |
| Date Received | 2014-02-19 |
| Model Number | 38 155 1S |
| Catalog Number | 38 155 1S |
| Lot Number | 445171 |
| Device Expiration Date | 2013-06-01 |
| 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 S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-19 |