MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for T-DOC AIR-CHARGED ANORECTAL MANOMETRY CATHETER TDOC-ARM4 manufactured by (unisensor Usa) Laborie Medical Technologies.
[100413371]
Patient Sequence No: 1, Text Type: N, H10
[100413372]
Patient was having an anorectal manometry procedure, and at the end of procedure, during defecation of the balloon, the balloon became detached from the probe and remained in the rectum. Nurse was not able to retrieve the balloon due to patient's discomfort. Patient sent to ed for removal. Of note, the balloon inflated/deflated without difficulty and was patent prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7281976 |
| MDR Report Key | 7281976 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-11-06 |
| Report Date | 2017-12-13 |
| Date Reported to FDA | 2017-12-13 |
| Date Reported to Mfgr | 2017-12-13 |
| Date Added to Maude | 2018-02-20 |
| 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 |
| 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 | T-DOC AIR-CHARGED ANORECTAL MANOMETRY CATHETER |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-02-20 |
| Model Number | TDOC-ARM4 |
| Lot Number | 100037 |
| Device Expiration Date | 2012-02-01 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | (UNISENSOR USA) LABORIE MEDICAL TECHNOLOGIES |
| Manufacturer Address | 112 CORPORATE DR STE 12 PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |