MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-19 for LATORIE RPC-9 manufactured by Laborie Medical Technologies Canada Ulc.
[5685661]
During a urodynamics procedure, when the rectal balloon catheter was removed from the patient at the end of the procedure, the balloon part separated from the catheter and remained in the patient. Patient was sent next door to the surgery center so a physician could remove the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681424-2015-00003 |
| MDR Report Key | 4648808 |
| Report Source | 06 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2014-11-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GERALD LONEY |
| Manufacturer Street | 6415 NORTHWEST DR., UNIT 11 |
| Manufacturer City | MISSISSAUGA, ON L4V 1X1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4V 1X1 |
| Manufacturer Phone | 6121170 |
| Manufacturer G1 | IMAK MEXICANA, S. DE R.L. DE C.V. |
| Manufacturer Street | BRECHE E-99 NORTE EDIFICIO 5 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSE, TAMAULIPAS, C.P. 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATORIE |
| Generic Name | ABDOMINAL PRESSURE CATHETER 9F |
| Product Code | FEN |
| Date Received | 2015-03-19 |
| Returned To Mfg | 2015-03-11 |
| Model Number | RPC-9 |
| Catalog Number | RPC-9 |
| Lot Number | CM14119 |
| Device Expiration Date | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES CANADA ULC |
| Manufacturer Address | 6415 NORTHWEST DR., UNIT 11 MISSISSAUGA, ON L4V1X1 CA L4V1X1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-19 |