MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 720157-01 manufactured by Boston Scientific Corporation.
[185914159]
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed. The event cannot be reproduced or substantiated. Related components of device system: model number/ catalog number: 72404127, serial number: n/a, batch/ lot number: 0147811018. Model/ catalog description: control pump fgs iz. Model number/ catalog number: 72400024, serial number: n/a, batch/ lot number: 0147781017, model/ catalog description: balloon fgs 61-70 cm.
Patient Sequence No: 1, Text Type: N, H10
[185914160]
It was reported that the patient experienced recurring incontinence due to urethral atrophy at the cuff site of his artificial urinary sphincter (aus). All components were removed and replaced with a new aus system. The patient had a good outcome with no further complication. Additional information received. The explanted 3. 5 cm cuff was replaced with a 4. 5 cm cuff. The previous cuff was the correct size and was placed in the correct location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01784 |
| MDR Report Key | 9908357 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2020-03-31 |
| 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 | 4089353452 |
| 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 | 2020-03-31 |
| Model Number | 720157-01 |
| Catalog Number | 720157-01 |
| Lot Number | 0141976003 |
| Device Expiration Date | 2017-07-14 |
| 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 | 2020-03-31 |