MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2014-05-29 for URINARY DRAINAGE BAGS 24 111 8-10 manufactured by Unomedical S.r.o..
[4668577]
Details of complaint: "customer ordered (b)(6), received a box marked with (b)(6) but packed with another product. "
Patient Sequence No: 1, Text Type: D, B5
[11969189]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. An investigation was conducted on (b)(4) 2011 based on the information provided by the customer and sample(s) received. The sample provided was tested and did not perform to our requirements. An analysis to determine the potential root cause indicates that the mistake was caused by operator inattention. It is concluded that the operators did not check the item number of packed products. Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from may 01, 2011 - september 30, 2013. Reported to the fda on (b)(4) 2014. Note: the actual date of event (b3) is unknown, so the date used was the date convatec became aware. Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00032 |
| MDR Report Key | 3908210 |
| Report Source | 01,06,07,08 |
| Date Received | 2014-05-29 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-31 |
| Date Mfgr Received | 2011-08-31 |
| Date Added to Maude | 2014-07-16 |
| 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 | MATTHEW WALENCIAK, INT. ASS. DIR |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAGS |
| Generic Name | KIT, URINARY DRAINAGE COLLECTIONS |
| Product Code | FCN |
| Date Received | 2014-05-29 |
| Returned To Mfg | 2011-09-06 |
| Model Number | 24 111 8-10 |
| Catalog Number | 24 111 8-10 |
| Lot Number | 364888 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-29 |