MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2015-02-27 for T-DOC T-DOC-7FD CAT880 manufactured by Laborie Medical Technologies Canada Ulc.
[5682092]
During urodynamic diagnostic procedure, then the urodynamic catheter was withdrawn from the patient's bladder, the sensor was missing.
Patient Sequence No: 1, Text Type: D, B5
[13039712]
The initial report from (b)(6) competent authority for medical devices was in (b)(4) language, difficult to understand and provided limited information. Once we received back the catheter on february 19, 2015 we were able to determine this ins a reportable event. The urodynamic catheter returned is missing 8 centimeters (3. 15 inches) or length from the urethral pressure sensor balloon to the distal tip of the catheter. Will follow up with customer to determine if a rigid scope and/or any surgical device or instrument was used at any time during the urodynamic procedure, including during catheter insertion and catheter withdrawal. This to ensure the catheter was not damaged by other means at the customer's location.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681424-2015-00001 |
| MDR Report Key | 4645901 |
| Report Source | 00,01 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-26 |
| Date of Event | 2014-11-13 |
| Date Mfgr Received | 2014-12-30 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-05-11 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GERALD LONEY |
| Manufacturer Street | 6415 NORTHWEST DR. UNIT 10 |
| Manufacturer City | MISSISSAUGA L4V1X1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4V1X1 |
| Manufacturer Phone | 6121170 |
| Manufacturer G1 | CLINICAL INNOVATIONS |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-DOC |
| Generic Name | 7FR DUAL SENSOR CATHETER |
| Product Code | FEN |
| Date Received | 2015-02-27 |
| Returned To Mfg | 2015-02-19 |
| Model Number | T-DOC-7FD |
| Catalog Number | CAT880 |
| Lot Number | 130912 |
| Device Expiration Date | 2015-08-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES CANADA ULC |
| Manufacturer Address | 6415 NORTHWEST DR. UNIT 11 MISSISSAUGA L4V1X1 CA L4V1X1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-27 |