MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-10 for T-DOC TDOC-7FSC CAT878 manufactured by Laborie Medical Technologies, Inc..
[21560233]
Customer reported that when they removed one cat875 urodynamic catheter from the package, they noticed a piece of internal wire was sticking out through the catheter wall. The catheter was not used on a pt and will be returned to laborie for investigation. If it had been used on a pt, there was potential that the wire could have made a tear in the urinary tract.
Patient Sequence No: 1, Text Type: D, B5
[21619276]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681424-2015-00004 |
| MDR Report Key | 4910095 |
| Report Source | 06 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2015-06-25 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. GERALD LONEY |
| Manufacturer Street | 6415 NORTHWEST DR., UNIT 10 |
| Manufacturer City | MISSISSAUGA, ON L4V 1X1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4V 1X1 |
| Manufacturer Phone | 6121170225 |
| Manufacturer G1 | CLINICAL INNOVATIONS |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-DOC |
| Generic Name | URODYNAMIC PRESSURE CATHETER |
| Product Code | FEN |
| Date Received | 2015-07-10 |
| Model Number | TDOC-7FSC |
| Catalog Number | CAT878 |
| Lot Number | 141136 |
| Device Expiration Date | 2016-12-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 6415 NORTHWEST DR., UNIT 10 MISSISSAUGA, ON L4V1X1 CA L4V 1X1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-10 |