MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED LONG APPLIER; CLIP, IMPLANTABLE

Catalog Number MCM30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/27/2023.D4: batch # unk.Additional information was requested and the following was obtained: have you been prescribed medication by a doctor (not over the counter medication)? yes.If yes, what is the doctor prescribed medication? lyrica, indomethacin, meloxicam, percoset / oxycodone, prednisone.Have you had any diagnostic testing done to address the symptoms you experienced? if yes, what diagnostic testing were completed? mri soft tissue neck, cta/ctv head/neck, emg, ultrasound neck.What are the next steps when it comes to the patients care? tried stellate ganglion never block (did not work).Further treatment in process of being determined." an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that post op to an unknown procedure, the patient has pain and inflammation in the neck and on the right side 24/7 has to take pain medication for pain.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17827207
• MDR Text Key: 324392023
• Report Number: 3005075853-2023-06915
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCM30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability