MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-07-19 for HARMONY? P3, SERVICE TEST CASE 4R147=S manufactured by Otto Bock Healthcare Lp.
[49944486]
This event occurred overseas in (b)(6) and has been translated accordingly per our affiliates in europe: a loaner system was provided to the customer in order to fit the patient with so that the patient was not immobilized during his/her repairs. Per the provided loaner kit, multiple functional rings are provided in order to allow the customer to choose the most appropriate fitting for the patient based on stiffness. The customer did not follow the provided instructions and ifu and did not appropriately tighten the functional ring to the pump system which is a requirement as specified in the instructions for use. The patient was using the product and while in use the functional ring became detached from the pump system and the patient fell to the ground. According to the initial reporter, the fall caused the patient to fracture his/her shoulder. Follow-up with regard to the health of the patient has been ongoing. At this point, multiple attempts to gain the additional information related to age, weight, height, patient sex and overall event details have been requested. All of this information has been documented in the record.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2016-00002 |
| MDR Report Key | 5806159 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-04-22 |
| Date Mfgr Received | 2016-05-24 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2016-07-19 |
| 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 | MR. CALEB BECK |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746647 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY? P3, SERVICE TEST CASE |
| Generic Name | VALVE, PROSTHESIS |
| Product Code | ISP |
| Date Received | 2016-07-19 |
| Returned To Mfg | 2016-05-24 |
| Model Number | 4R147=S |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 SALT LAKE CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |