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 2020-03-18 for BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL 170605-000160 manufactured by Teleflex Medical Sdn. Bhd..
[186333506]
(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
[186333507]
The report states: we faced 3 issues with balloon deflation with catalog #171305, according to sales representative the size was ch 16. The consequences for the 3 patients were that a new catheter was inserted. The catheters were used for drainage. There is no device to be sent back for investigation. The customer stated the balloons were not fully deflated at removal, clarification about that fact was asked to the customer and the customer was not able to provide any further explanation about that fact. The customer was only able to report issue with balloons deflation (3 attempts made (b)(6) 2020). Clinical consequences: the balloons had to be re-inflated. And the catheters had to be replaced more often that it should be.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00086 |
| MDR Report Key | 9847837 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-18 |
| 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 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, CYLINDRICAL |
| Product Code | EZL |
| Date Received | 2020-03-18 |
| Catalog Number | 170605-000160 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-18 |