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 2019-04-23 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[142771226]
(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: did the tip of the needle break off during the index neuro procedure? Or did the tip of the needle break off when the patient was brought back for ind (incision and drainage procedure)? -needle broke off during the original neuro procedure. If the needle tip broke during the ind procedure, was the needle tip removed during the ind procedure? Tip was found during i&d procedure and removed. Date of the ind procedure unknown. The patient demographic info: age, gender, weight, bmi at the time of index procedure - unknown and name of index surgical procedure - unknown. What instruments were used to grasp the needle? Unknown. Where was the needle grasped during use? Unknown. Product code and lot # - unknown. If applicable, will product be returned, return date, tracking information- no. Hospital disposed of product. What is physician? S opinion as to the etiology of or contributing factors to this event- unknown. What is the patient current status? Unknown. Post op after the incision and drainage procedure the patient was brought back because of an infection. The surgeon was not sure of the cause.
Patient Sequence No: 1, Text Type: N, H10
[142771227]
It was reported that the patient underwent an unknown neurological procedure on an unknown date and suture was used. During the procedure, the tip of the needle broke off. When the patient was brought back for ind (incision and drainage procedure) on an unknown date, the tip floated to the top when they irrigated and removed the tip. The patient? S current status is unknown. Post-op after the incision and drainage procedure the patient was brought back because of an infection. The surgeon was not sure of the cause. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-80612 |
| MDR Report Key | 8540151 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-23 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-04-23 |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GAK |
| Date Received | 2019-04-23 |
| 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. Required No Informationntervention | 2019-04-23 |