MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-24 for SVCE REPL SPIDER 2 TENET 7615 72203299S manufactured by Smith & Nephew, Inc..
[181620492]
It was reported that during case the spider was not holding the arm. It is unknown if there was a delay or backup device available. No patient injuries reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1643264-2020-00099 |
MDR Report Key | 9748541 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2020-02-24 |
Date of Report | 2020-03-19 |
Date of Event | 2020-01-23 |
Date Mfgr Received | 2020-03-17 |
Date Added to Maude | 2020-02-24 |
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 | HOLLY TOPPING |
Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
Manufacturer City | AUSTIN TX 78735 |
Manufacturer Country | US |
Manufacturer Postal | 78735 |
Manufacturer Phone | 5123913905 |
Manufacturer G1 | SMITH & NEPHEW, INC. |
Manufacturer Street | 76 S. MERIDIAN AVE. |
Manufacturer City | OKLAHOMA CITY OK 731076512 |
Manufacturer Country | US |
Manufacturer Postal Code | 731076512 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SVCE REPL SPIDER 2 TENET 7615 |
Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
Product Code | GDC |
Date Received | 2020-02-24 |
Returned To Mfg | 2020-03-05 |
Catalog Number | 72203299S |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW, INC. |
Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-24 |