MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for OTTO BOCK CUSTOM BK REPLACEMENT LINER 6Y402 manufactured by Otto Bock Healthcare Lp.
[66032319]
Recently otto bock healthcare lp performed a retrospective review accross all products manufactured in (b)(4). During the review this malfunction was discovered and it was determined to be reportable based on the criteria outlined in 21 cfr 803.
Patient Sequence No: 1, Text Type: N, H10
[66032320]
Customer reported that while the end-user was wearing the liner, "pin pulled out of liner, threads in the distal umbrella are stripped out. Patient fell. " no other information was provided from the customer or end-user regarding the severity of the fall. Out of an abundance of caution this complaint was reported as an mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2017-00001 |
| MDR Report Key | 6278019 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-26 |
| Date of Event | 2013-12-26 |
| Date Mfgr Received | 2013-12-26 |
| Date Added to Maude | 2017-01-25 |
| 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 | STEPHEN ANDERSON |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8014257213 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTTO BOCK CUSTOM BK REPLACEMENT LINER |
| Generic Name | 6Y402, OTTO BOCK CUSTOM BK REPLACEMENT LINER |
| Product Code | ISS |
| Date Received | 2017-01-25 |
| Returned To Mfg | 2014-02-27 |
| Model Number | 6Y402 |
| Catalog Number | 6Y402 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE LP |
| Manufacturer Address | 3820 WEST GREAT LAKES DRIVE WEST VALLEY CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |