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 2018-03-27 for RADIOPAQUE UMBILICAL TAPE 24"(60CM) WHI U16G manufactured by Ethicon Inc..
[103554651]
(b)(4). 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. Additional information was requested and the following was obtained: please clarify the event "umbilical tape isn? T holding in heart cases when it gets wet for aortic dissection": did the suture break in the middle during use? Yes. Was there any patient adverse event? No. Was medical or surgical intervention required to address the issue? No.
Patient Sequence No: 1, Text Type: N, H10
[103554652]
It was reported that a patient underwent an aortic valve repair on (b)(6) 2018 and suture was used. During the procedure, the suture broke and was not holding in the heart case when it got wet for aortic dissection. There was no intervention required and no adverse patient consequences. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-71671 |
| MDR Report Key | 7373319 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-27 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-27 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIOPAQUE UMBILICAL TAPE 24"(60CM) WHI |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2018-03-27 |
| Catalog Number | U16G |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |