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 2019-05-01 for COTTON UMBILICAL TAPE 2-18" (45CM) WHT U10T manufactured by Ethicon Inc..
[143742057]
(b)(4). A manufacturing record evaluation was performed for the finished device ah0051 number, and no non-conformances were identified. 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: gender, weight, bmi at the time of index procedure? What were current symptoms following the index procedure? Onset date and time? Amount of blood loss? Was medical intervention performed for the patient bleeding? What was the appearance of the cotton umbilical tape during the reoperation/resuturing? What is the physician? S opinion as to the etiology of or contributing factors to this event? Does the surgeon believe there was an alleged deficiency with the device? What is the patient? S current status?
Patient Sequence No: 1, Text Type: N, H10
[143742058]
It was reported that a newborn underwent an umbilical cord procedure on an unknown date and cotton umbilical suture was used. The nurse placed an emergent call with a newly born infant in the arms and infant was cyanotic, moderate bleeding by umbilical cord observed in the diaper. The nurse immediately reported this to the pediatric department and physician attending the call assessed the neonate and saw that the league that has the newborn is fixed in the cord but still does not achieve hemostasis. The bleeding persisted and physician proceeded to link the suture with non-absorbable suture. The physician called a pediatrician who ordered hospitalization of the neonate in the neonatal intermediate care area. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-80932 |
| MDR Report Key | 8570668 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-06 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2019-05-01 |
| 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 |
| Manufacturer G1 | ETHICON INC.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240-908 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240-908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON UMBILICAL TAPE 2-18" (45CM) WHT |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | EXM |
| Date Received | 2019-05-01 |
| Catalog Number | U10T |
| Lot Number | AH0051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-01 |