MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-16 for REBOUND AIR WALKER B-242900004E manufactured by Ossur Hf.
[145208659]
Patient reported injury regarding severely reduced blood circulation leading to acute thrombosis. It is unclear which other (dvt risk) factors could have contributed to this injury. Circumstances are under investigation in order to determine the potential contributing role of the walker. Ossur is not aware of similar injuries due to the use of the rebound air walker.
Patient Sequence No: 1, Text Type: N, H10
[145208660]
Acute thrombosis occluding the sfa, popliteal, peroneal and gastrocnemius veins. This resulted in admission to hospital for 3 days and blood thinner for 3 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002085446-2019-00001 |
| MDR Report Key | 8614756 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-16 |
| Date of Report | 2019-07-04 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-16 |
| 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 | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REBOUND AIR WALKER |
| Generic Name | EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2019-05-16 |
| Model Number | B-242900004E |
| Catalog Number | B-242900004E |
| Lot Number | WB180926 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-16 |