MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-05-14 for RADISTOP RADIAL COMPRESSION SYSTEM C11177 manufactured by St. Jude Medical Systems Ab.
[3568658]
A radistop compression device was used on the right radial artery. Following use, a hematoma developed requiring surgical evacuation. No add'l info was rec'd.
Patient Sequence No: 1, Text Type: D, B5
[10710163]
The product was not returned; however, we do not believe the cause of the hematoma was due to a device malfunction or any deficiency with the instructions for use requiring corrective action. We will continue to closely monitor the performance of this product for any significant trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030904-2013-00009 |
| MDR Report Key | 3122491 |
| Report Source | 05,06,07 |
| Date Received | 2013-05-14 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-03-14 |
| Date Mfgr Received | 2013-04-15 |
| Date Added to Maude | 2013-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMIL ANDERAS |
| Manufacturer Street | PALMBLADSGATAN 10 BOX 6350 |
| Manufacturer City | UPPSALA SE-751 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-751 35 |
| Manufacturer Phone | 8161000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADISTOP RADIAL COMPRESSION SYSTEM |
| Generic Name | TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2013-05-14 |
| Model Number | C11177 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL SYSTEMS AB |
| Manufacturer Address | PALMBLADSGATAN 10 BOX-6350 UPPSALA SE-751 3 SW SE-751 35 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-14 |