MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for OTTOBOCK HARMONY? P4 HD MECHANICAL PUMP 4R181 manufactured by Otto Bock Healthcare Lp.
[143239250]
.
Patient Sequence No: 1, Text Type: N, H10
[143239251]
As reported by the prescribing / fitting practitioner ((b)(6)), "we recently had a patient being fit with a p4 pump. During the test fit phase, our technicians had scratched up the top of the mounting plate in order to give it more bonding surface area. The mounting plate was attached to the socket using fab tec two part resin. Then the plate and socket were bonded together with fiberglass wrap. The patient left our facility and later that night the mounting plate completely separated from the socket. Unfortunately, the patient fell and dislocated his shoulder. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2019-00002 |
| MDR Report Key | 8551262 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2019-04-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN ANDERSON |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746676 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTTOBOCK HARMONY? P4 HD MECHANICAL PUMP |
| Generic Name | 4R181 HARMONY? P4 HD MECHANICAL PUMP |
| Product Code | ISP |
| Date Received | 2019-04-25 |
| Model Number | 4R181 |
| Catalog Number | 4R181 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2019-04-25 |