MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-09 for UROPASS AS 10/12FR X 38 CM 5/BX 61038BX manufactured by Teleflex Medical Oem.
[178190092]
The access sheath will not be returned for evaluation as it was discarded by the user facility after the procedure. The exact cause of the reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[178190093]
The manufacturer was informed that during a ureter procedure, the access sheath broke and perforated the patient? S ureter. The injury was treated during the procedure. The intend procedure was completed. The procedure was delayed an additional 30 minutes. The patient is doing well and under observation pending review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00310 |
| MDR Report Key | 9571876 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-01-09 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROPASS AS 10/12FR X 38 CM 5/BX |
| Generic Name | UROPASS AS 10/12FR X 38 |
| Product Code | KNY |
| Date Received | 2020-01-09 |
| Model Number | 61038BX |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |