MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-04-20 for AMS ACTICON NEOSPHINCTER 72402106 manufactured by Boston Scientific - Minnetonka.
[106091958]
Same patient/device as: 2183959-2018-00037. It was reported that following the removal of the acticon artificial bowel sphincter cuff and pump components), the patient had the balloon component removed due to infection, sepsis, and a cutaneous abscess of the abdominal wall. The patient was admitted to the emergency department (ed) on (b)(6) 2017 due to "intra-abdominal abscess post-procedure", "sepsis", fever, infection, and complaints of lower abdominal pain, chills, discomfort, erythematous area right and inferior suprapubic region, and vaginal discharge. Purulent fluid was found surrounding the reservoir and associated tubing. All foreign material was removed, purulent discharge was removed, area was flushed, suctioned, and a wound vac was placed. The patient was also treated with iv antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2018-00049 |
| MDR Report Key | 7447976 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-02 |
| Date Mfgr Received | 2018-04-02 |
| Device Manufacturer Date | 2003-04-03 |
| Date Added to Maude | 2018-04-20 |
| 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 | 2018-04-20 |
| Catalog Number | 72402106 |
| Device Expiration Date | 2008-04-01 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-04-20 |