MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-09 for URINARYDRAINAGE BAG W/ANTI-REFLUX 390060 manufactured by Teleflex Medical.
[45477821]
(b)(4). The device has not been returned for investigation at this time. There were no issues or returns noted at the manufacturing origin with this lot or model number. The description of the issue is not clear enough to draw any conclusion. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[45477822]
Reported event: the bag would not allow urine to flow in through the anti-reflux device. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00093 |
| MDR Report Key | 5641330 |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-05-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URINARYDRAINAGE BAG W/ANTI-REFLUX |
| Product Code | FAQ |
| Date Received | 2016-05-09 |
| Catalog Number | 390060 |
| Lot Number | 20141225 |
| Device Expiration Date | 2019-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-09 |