MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-23 for AMS ACTICON NEOSPHINCTER manufactured by American Medical Systems (mn).
[5765446]
It was reported that the acticon bowel sphincter 12. 0cm cuff and 101-110 cm h2o balloon were removed due to cuff atrophy and the balloon "pressure was not enough to close cuff. " another acticon 11. 0cm cuff and a 101-110 cm h2o balloon were implanted. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13089898]
Components in order of cuff, balloon. Catalog #: 72401982, 72402106; expiration date: 02/04/2014, 07/08/2014; serial #: (b)(4). If implanted, give date: (b)(6) 2009, (b)(6) 2010. Device manufacture date: 02/06/2009, 07/22/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2015-00112 |
| MDR Report Key | 4622587 |
| Report Source | 05 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-02-11 |
| Date Mfgr Received | 2015-02-27 |
| Date Added to Maude | 2015-03-23 |
| 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 | 0 |
| Event Location | 0 |
| 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 | AMERICAN MEDICAL SYSTEMS (MN) |
| 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 | 2015-03-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-03-23 |