MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER RMD-002-004 manufactured by Medspira Llc.
[137973962]
During biofeedback session, balloon part of the biofeedback catheter broke while in the patient. Manufacturer response for anorectal manometry catheter, mcompass biofeedback 2, channel anorectal manometry catheter (per site reporter). This is apparently one of four cases of this type for this particular device/lot number experienced by (b)(6) hospitals during the month of january. Company has been made aware and have made arrangements to replace all existing stock with this lot number. Unaware if other follow up has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8394218 |
| MDR Report Key | 8394218 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-24 |
| Report Date | 2019-02-18 |
| Date Reported to FDA | 2019-02-18 |
| Date Reported to Mfgr | 2019-03-06 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER |
| Generic Name | DEVICE, BIOFEEDBACK |
| Product Code | HCC |
| Date Received | 2019-03-06 |
| Model Number | RMD-002-004 |
| Catalog Number | RMD-002-004 |
| Lot Number | 18122004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSPIRA LLC |
| Manufacturer Address | 2718 SUMMER STREET NE MINNEAPOLIS MN 55413 US 55413 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-06 |