MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2014-02-12 for URINARY DRAINAGE BAGS 48-110-1S-20 manufactured by Unomedical S.r.o..
[19299233]
Urine won't drain into the bag.
Patient Sequence No: 1, Text Type: D, B5
[19452231]
Based on the information provided this event is deemed a reportable malfunction. An e-mail requesting additional information was sent to the complainant on (b)(6) 2014, and the response was received (b)(4) 2014 as there was a new device with a different lot was reinserted; no medical treatment required for patient and no medical information regarding patient could be provided. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00004 |
| MDR Report Key | 3802015 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-01-20 |
| Date of Event | 2014-01-17 |
| Date Mfgr Received | 2014-01-20 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-05-27 |
| 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 | 0 |
| Manufacturer Contact | MARY SZARO, ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| 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 | 2014-02-12 |
| Model Number | 48-110-1S-20 |
| Catalog Number | 48-110-1S-20 |
| Lot Number | 466855 |
| Device Expiration Date | 2018-01-01 |
| 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 | 2014-02-12 |