MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2006-09-25 for LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM manufactured by Bioenterics Corporation.
[15037086]
Reported as, "leak of access port. "
Patient Sequence No: 1, Text Type: D, B5
[15454829]
Visual examination of the returned device determined the access port tubing connector to be a taper i. Analysis of the device noted damage from a sharp instrument to both the band tubing and the port tubing. There was no indication of wear related damage to the portion of the lap-band system returned. Performance tests indicate no leakage at the access port or access port tubing other than damage from sharp instrument noted above. The lab was unable to duplicate or confirm the reported event. There is no other info available at this time from the surgeon to determine the cause of the alleged event. Device labeling addresses the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port or the connector tubing. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024601-2006-00563 |
| MDR Report Key | 863711 |
| Report Source | 01,05,08 |
| Date Received | 2006-09-25 |
| Date of Report | 2006-08-28 |
| Date of Event | 2006-07-11 |
| Date Mfgr Received | 2006-08-28 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2007-06-12 |
| 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 | 0 |
| Manufacturer Contact | TIM KIRKELIE |
| Manufacturer Street | 700 WARD DR. |
| Manufacturer City | SANTA BARBARA CA 93111 |
| Manufacturer Country | US |
| Manufacturer Postal | 93111 |
| Manufacturer Phone | 8006244261 |
| Manufacturer G1 | BIOENTERICS CORP. |
| Manufacturer Street | 1035 CINDY LANE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM |
| Generic Name | DEVICE FOR TREATMENT OF MORBID OBESITY |
| Product Code | LTT |
| Date Received | 2006-09-25 |
| Returned To Mfg | 2006-09-18 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | S00LB140 |
| ID Number | NA |
| Device Expiration Date | 2002-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 846068 |
| Manufacturer | BIOENTERICS CORPORATION |
| Manufacturer Address | 1035 CINDY LANE CARPINTERIA CA 93013 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-25 |