MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for TUBE SET FOR IRRIGATION, SINGLE-USE AQL-110 manufactured by W.o.m. World Of Medicine Gmbh.
[177157268]
When plugging into the hysteroscopy pump, the tubing started leaking by the rfid hub. Product did not have patient contact and no harm to patient. Failed product is available to be returned to the manufacturer. New tubing was opened to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652876 |
| MDR Report Key | 9652876 |
| Date Received | 2020-01-31 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-05 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| 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 | TUBE SET FOR IRRIGATION, SINGLE-USE |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2020-01-31 |
| Model Number | AQL-110 |
| Catalog Number | AQL-110 |
| Lot Number | K19BO56 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M. WORLD OF MEDICINE GMBH |
| Manufacturer Address | 4531 36TH ST ORLANDO FL 32811 US 32811 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |