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 2014-04-29 for URINARY DRAINAGE BAGS 37 452 0-10 manufactured by Unomedical S.r.o..
[15877072]
Based on the available information, this event is deemed to be a serious injury as it was potentially life threatening (risk of aspiration of emesis), and medical intervention has been required to treat wound infection. From a preliminary clinical perspective, a causal relationship between the urostomy drain bag and this event is deemed possible because the tubing was noted to be kinked. It is of note however, that the use of this product for collection of stomach contents from an ng tube is not an indication included in the labeling. A quality evaluation was conducted by third party manufacturer on (b)(4) 2011 based on the information received by the customer and sample received. One sample was received and tested, including visual inspection of the tube, and the test which showed how quickly the urine (according to intended use of the device) would have been drained into the bag according to strict international standard valid for this kind of medical equipment (iso 8669-2, 6. 10) and we determined that it met our quality requirements. No deviations in connection with this issue were registered during the manufacturing process. No other complaints have been received on the batch, in addition a similar issue has been already investigated under a separate event identifier. Note: the actual date of event is unknown, so the date used was the date convatec became aware. Note: this mdr is being reported as a result of a retrospective review of complaints conducted by convatec for complaints received from (b)(4) 2013. 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
[15999008]
It is reported that the pouch was connected to a stomach tube, stop in the tube to the pouch (uropouchs tube). The pt was an unknown number of days post-op for a cystectomy. An ng tube was in place and it was connected to an unomedical urostomy pouch for passive drainage of stomach contents during the post op period. It was claimed that the "inlet tube" of the urine bag was blocked/kinked, causing an obstruction. The pt apparently vomited and thereafter the ng tub was removed. It is yet unknown if the ng tube was replaced after the vomiting ceased. It was discovered that the abdominal wound had dehisced "approximately 2x3 cm x 2 cm. Deep". The wound is reported to be infected and the pt is being treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2014-00013 |
| MDR Report Key | 3788400 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-04-29 |
| Date of Report | 2011-05-02 |
| Date of Event | 2011-05-02 |
| Date Mfgr Received | 2011-05-02 |
| Date Added to Maude | 2014-05-06 |
| 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 | MATTHEW WALENCIAK, INTERIM ASSOCI |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAGS |
| Generic Name | INDWELLING CATHETER DRAINAGE COLLECT 78FCN |
| Product Code | FCN |
| Date Received | 2014-04-29 |
| Returned To Mfg | 2011-05-20 |
| Model Number | 37 452 0-10 |
| Catalog Number | 37 452 0-10 |
| Lot Number | 404951 |
| 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 | 1. Required No Informationntervention | 2014-04-29 |