MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-15 for AMS ACTICON NEOSPHINCTER SEE H10 manufactured by Boston Scientific - Minnetonka.
[97293445]
Catalog #: cuff - 72401958, pump - 72402287, balloon - 72402106. Expiration date: cuff - 4/7/2014, pump - 3/9/2014, balloon - 2/20/2014. Serial #: cuff - (b)(4), pump - (b)(4), balloon - (b)(4). Manufacture date: cuff - 4/9/2009, pump - 3/9/2009, balloon - 3/3/2009.
Patient Sequence No: 1, Text Type: N, H10
[97293446]
It was reported the patient had her artificial bowel sphincter removed and replaced due to infection. No further patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2018-00011 |
| MDR Report Key | 7188956 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-15 |
| Date of Report | 2018-01-10 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-01-15 |
| 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 | MRS. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MINNETONKA |
| 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 ACTICON NEOSPHINCTER |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | MIP |
| Date Received | 2018-01-15 |
| Catalog Number | SEE H10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINNETONKA |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-15 |