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 2019-11-26 for AIRSEAL 12/100MM LPI PORT IAS12-100LPI manufactured by Sequel Special Products.
| Report Number | 1320894-2019-00405 |
| MDR Report Key | 9375048 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-11-08 |
| Date Added to Maude | 2019-11-26 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Street | 1 HILLSIDE DR |
| Manufacturer City | WOLCOTT CT 06716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRSEAL 12/100MM LPI PORT |
| Generic Name | INSUFFLATOR, LAPAROSCOPIC |
| Product Code | HIF |
| Date Received | 2019-11-26 |
| Catalog Number | IAS12-100LPI |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Address | 1 HILLSIDE DR WOLCOTT CT 06716 US 06716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |