MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-09 for 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER manufactured by Otto Bock Healthcare Lp.
[67381314]
Recently otto bock healthcare performed a retrospective review for complaints across 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
[67381315]
Customer reported that liner umbrella was separating from the distal end of the liner. No adverse event was reported by the customer or end-user as a result of this specified failure. As this specific failure has potential to cause serious injury, out of an abundance of caution this complaint will be reported as an mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2017-00002 |
| MDR Report Key | 6316156 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-09 |
| Date of Report | 2017-02-09 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2017-02-09 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER |
| Generic Name | 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER |
| Product Code | ISS |
| Date Received | 2017-02-09 |
| Returned To Mfg | 2015-04-17 |
| 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 | 2017-02-09 |