MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-27 for AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 720157-01 manufactured by Boston Scientific Corporation.
[146200223]
Model number/catalog number: 72404130, serial number: null, batch/lot number: 1000191511, model/catalog description: belt cuff fgs 4. 0 cm iz; model number/catalog number: 72404127, serial number: null, batch/lot number: 1000204956, model/catalog description: control pump fgs iz; model number/catalog number: 72400024, serial number: null, batch/lot number: 1000204066, model/catalog description: balloon fgs 61-70 cm.
Patient Sequence No: 1, Text Type: N, H10
[146200224]
It was reported that the patient experienced erosion with and artificial urinary sphincter (aus), leading to it being previously removed. A reimplant surgery was performed. The patient was did not present any additional adverse events. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2019-63460 |
| MDR Report Key | 8644344 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-27 |
| Date of Report | 2019-05-27 |
| Date of Event | 2019-05-14 |
| Date Mfgr Received | 2019-05-14 |
| Device Manufacturer Date | 2018-12-17 |
| Date Added to Maude | 2019-05-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALYSON HARRIS |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 4083953452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE |
| Generic Name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Product Code | EZY |
| Date Received | 2019-05-27 |
| Model Number | 720157-01 |
| Catalog Number | 720157-01 |
| Lot Number | 1000207918 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-27 |