MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-22 for GIA PREMIUM 030735L manufactured by Us Surgical Puerto Rico.
| Report Number | 2647580-2019-03767 |
| MDR Report Key | 8810333 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-22 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-07-04 |
| Date Mfgr Received | 2019-07-04 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-07-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIA PREMIUM |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2019-07-22 |
| Model Number | 030735L |
| Catalog Number | 030735L |
| Lot Number | P8L1191Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-22 |