MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for AMS 800 URINARY CONTROL SYSTEM UNK-P-AUS manufactured by Boston Scientific Corporation.
[185895626]
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint. The reported allegations could not be confirmed. The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Patient Sequence No: 1, Text Type: N, H10
[185895627]
It was reported that the patient experienced recurring incontinence leading to an artificial urinary sphincter (aus) replacement surgery. During the procedure the existing device was removed and a new aus was implanted. The physician believed the incontinence was cause by atrophy and possibly scarring. The patient was said to be in recovery following the procedure. It was further reported that the explanted and new cuffs were both 4. 0 cm. The physician did not feel an incorrect cuff size or location were related to the previous cuff. The patient did have a history of radiation therapy. There were no device malfunctions associated with the explanted device. The patient was said to be recovering following the procedure. 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 | 2183959-2020-01641 |
| MDR Report Key | 9887027 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Generic Name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Product Code | EZY |
| Date Received | 2020-03-26 |
| Model Number | UNK-P-AUS |
| Catalog Number | UNK-P-AUS |
| 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 | 2020-03-26 |