MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-12 for BRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2 171305-000120 manufactured by Teleflex Medical Sdn. Bhd..
[186332478]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[186332479]
It was reported that for a (b)(6)-year-old patient, (b)(6) kg. There was leakage of the catheter. Happened with 4 patients. The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients. Information was provided on (b)(6) 2020 to customer to inform about issues that can occur with old patients (bladder neck distends). The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients. The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00075 |
| MDR Report Key | 9823961 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-12 |
| 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 | RISK MANAGER |
| 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 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2 |
| Product Code | EZL |
| Date Received | 2020-03-12 |
| Catalog Number | 171305-000120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |