MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-17 for TDOC AIR-CHARGED CATHETER CAT 880 manufactured by Laborie Medical Technologies Canada Ulc.
[139186684]
This incident did not result in a serious injury of the patient or require medical intervention; however, this event is being reported to the fda based on a review of the risk documentation for the device which identified that were this malfunction to occur again, there is the possibility that medical intervention might be necessary.
Patient Sequence No: 1, Text Type: N, H10
[139186685]
A laborie catheter which was used in a male patient in (b)(6) as part of a urodynamics study had a steel wire protruding from the catheter. The physician either did not notice the defect prior to inserting the catheter into the patient, or the defect occurred after insertion into the patient - we are unable to tell based on the information provided - which resulted in the patient's urethra receiving minor scratches upon removal of the catheter. No medical intervention was required as a result of this product malfunction; the patient was released and did not require additional follow-up or treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681424-2019-00001 |
| MDR Report Key | 8427288 |
| Date Received | 2019-03-17 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-03-17 |
| 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. NICOLE BOSER |
| Manufacturer Street | 6415 NORTHWEST DRIVE UNIT 10 |
| Manufacturer City | MISSISSAUGA, ONTARIO L4V1X1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4V1X1 |
| Manufacturer G1 | CLINICAL INNOVATIONS LLC |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TDOC AIR-CHARGED CATHETER |
| Generic Name | CATHETER FOR USE WITH URODYNAMIC SYSTEM |
| Product Code | FEN |
| Date Received | 2019-03-17 |
| Returned To Mfg | 2019-02-25 |
| Model Number | CAT 880 |
| Lot Number | 180716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 10 MISSISSAUGA, ONTARIO L4V1X1 CA L4V1X1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-17 |