MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for VISTASEAL LAPAROSCOPIC DUAL APPLICATOR R VSTL35 manufactured by Ethicon Inc..
[188067609]
(b)(4). Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[188067610]
It was reported that a patient underwent an unknown procedure on an unknown date and a fibrin sealant was used. Pre-operatively, when they opened the package a hair was present. Case completed with another device of the same product code. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01975 |
| MDR Report Key | 9821970 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-11 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | VIANT AS&O HOLDINGS INC. |
| Manufacturer Street | 45 LEXINGTON DRIVE |
| Manufacturer City | LACONIA NH 03246 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISTASEAL LAPAROSCOPIC DUAL APPLICATOR R |
| Generic Name | FIBRIN SEALANT PREPARATION DEVICE |
| Product Code | MZM |
| Date Received | 2020-03-11 |
| Model Number | VSTL35 |
| Catalog Number | VSTL35 |
| Lot Number | 4870583 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |