MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-19 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.
Report Number | 1610287-2019-00019 |
MDR Report Key | 8714190 |
Date Received | 2019-06-19 |
Date of Report | 2019-07-23 |
Date Mfgr Received | 2019-07-08 |
Device Manufacturer Date | 2019-01-17 |
Date Added to Maude | 2019-06-19 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 | MS. CINDY MILAM |
Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
Manufacturer City | FORT WORTH TX 76134 |
Manufacturer Country | US |
Manufacturer Postal | 76134 |
Manufacturer Phone | 8176152231 |
Manufacturer G1 | AIR LIQUIDE |
Manufacturer Street | 13140 TI BLVD. |
Manufacturer City | DALLAS TX 75243 |
Manufacturer Country | US |
Manufacturer Postal Code | 75243 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ISPAN GAS TANK REGULATOR |
Generic Name | INTRAOCULAR GAS |
Product Code | LPO |
Date Received | 2019-06-19 |
Returned To Mfg | 2019-06-20 |
Model Number | NA |
Catalog Number | 8065797303 |
Lot Number | 901708 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AIR LIQUIDE |
Manufacturer Address | 13140 TI BLVD. DALLAS TX 75243 US 75243 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-19 |