MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN

Catalog Number SURGICAL UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033)

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation thus we are unable to determine if it is a teleflex product.None the less, teleflex will continue to monitor and trend related events.

Event Description

Is there anyone else i can contact to get more information on the horizon titanium ligating clips, such as the grade of pure elemental titanium, as those do have a small percentage of other elements such as iron, hydrogen, carbon, nitrogen and oxygen.That is for grades 1-4 pure titanium.If it is a higher grade(alloy), it could have palladium , nickel or mylobdenum.This is very concerning to me as i have a lot of these clips in me and have been experiencing chronic pain in the areas of the clips along with a rash and intense itching.I'm working with my doctor's to get this figured out and we need as much information about these clips as possible so we know what to test to see if it is a hypersensitivity reaction.

Event Description

Is there anyone else i can contact to get more information on the horizon titanium ligating clips, such as the grade of pure elemental titanium, as those do have a small percentage of other elements such as iron, hydrogen, carbon, nitrogen and oxygen.That is for grades 1-4 pure titanium.If it is a higher grade(alloy), it could have palladium , nickel or mylobdenum.This is very concerning to me as i have a lot of these clips in me and have been experiencing chronic pain in the areas of the clips along with a rash and intense itching.I'm working with my doctor's to get this figured out and we need as much information about these clips as possible so we know what to test to see if it is a hypersensitivity reaction.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: SURGICAL UNKNOWN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13620389
• MDR Text Key: 289071209
• Report Number: 3003898360-2022-00036
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.