MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-17 for AMS ACTICON NEOSPHINCTER SEE H10 manufactured by American Medical Systems (mn).
[5051625]
It was reported that the patient had her acticon device replaced due to fluid loss at the balloon. No patient complications were reported in relation with this event.
Patient Sequence No: 1, Text Type: D, B5
[12518823]
Balloon catalog #72402105; exp. Date: 04/27/2012; serial # (b)(4); mfg. Date: 05/2007; pump catalog #72402287; exp. Date: 07/24/2012; serial # (b)(4); mfg. Date: 07/2007; cuff catalog # 72401978. The explanted device was returned and analyzed. Results indicate there was a fluid leak in the cuff due to wear at a fold. The balloon sustained a leak which was consistent with a hole caused a sharp instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2014-00526 |
| MDR Report Key | 4253971 |
| Report Source | 05 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-11-17 |
| 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 | 2014-11-17 |
| Returned To Mfg | 2014-11-12 |
| Catalog Number | SEE H10 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-11-17 |