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 2018-10-05 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[122851828]
(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: what tissue was the needle being used on? Can you provide the product code / suture name / lot number used? Did the needle separate from the suture? Did the needle break during use? How was the needle being held during use? What tissue was the half of needle retained in? Were the needle pieces removed from the patient? What is the date of the second procedure to remove the needle? Do you have the needle to return for evaluation? What are the patient age, gender, weight, medical history? What is the current condition of the patient? I don? T have the lot or code. Needle broke during use. Needle was broken in half w no suture on it.
Patient Sequence No: 1, Text Type: N, H10
[122851829]
It was reported that a patient underwent total knee procedure on (b)(6) 2018 and suture was used. The needle broke during use. The patient required an additional procedure to remove the needle half. The current status of the patient is unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-76338 |
| MDR Report Key | 7938878 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-10-05 |
| 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, SYNTHETIC |
| Product Code | GAK |
| Date Received | 2018-10-05 |
| Catalog Number | UNK |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-05 |