MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-09 for GOLD POST-OP 3-W LATEX FOLEY, CYL. 183430-000180 manufactured by Teleflex Medical.
| Report Number | 8040412-2019-00248 |
| MDR Report Key | 8976962 |
| Date Received | 2019-09-09 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-10-10 |
| Date Added to Maude | 2019-09-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, 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 | GOLD POST-OP 3-W LATEX FOLEY, CYL. |
| Product Code | FCM |
| Date Received | 2019-09-09 |
| Returned To Mfg | 2019-09-30 |
| Catalog Number | 183430-000180 |
| Lot Number | 18D11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-09 |