3.2MM PELLET INSERTION TRAY #2 - STERILE / LATEX FREE
Report
- Report Number
- 2433012-2024-00001
- Event Type
- Injury
- Date Received
- September 28, 2024
- Report Date
- September 27, 2024
- Manufacturer
- 75 ARKAY DRIVE
- Product Code
- FBQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 117
Narratives
ON (B)(6), 2024 (B)(6) HOSPITAL DISPOSABLES (BHD) RECEIVED AN EMAIL FROM OUR SALES REPRESENTATIVE, NOTIFYING US OF A REPORT OF A CUSTOM KIT BUSSE MANUFACTURES FOR BOND THERAPEUDICS (BONDS) - CAT#B6705R2. THE REPORT NOTED, INQUIRY TO KNOW WHETHER BHD HAD RECEIVED ANY COMPLAINTS ON TEGADERM. THE EMAIL INCLUDED ATTACHMENT OF BHD DEVICE COMPLAINT FORM, FURTHER DESCRIBING THE FOLLOWING: "WE [(B)(6)] RECEIVED A CALL FROM A CUSTOMER INDICATING AN ADVERSE REACTION TO THE TEGADERM DRESSING INCLUDED IN THE KITS. THE CLAIM FROM THE ASSOCIATE IN THE DOCTORS OFFICE WAS THAT THERE WERE (B)(4) PATIENTS WHO HAD AN ALLERGIC REACTION AFTER LEAVING THE DOCTORS OFFICE. THEY MENTIONED THEY HAD NEVER HAD THIS PROBLEM IN THE PAST AND WANTED TO ALERT US TO IT. THERE IS NO FURTHER INDICATIONS OF INFECTION OR OTHER REACTIONS, BUT WE HAVE JUST RECEIVED THE COMPLAINT.' *IT IS IMPORTANT TO CLARIFY THAT WHILE THE (B)(6) IS REFERING TO THE PRODUCT AS TEGADERM, THE CATALOG DOES NOT CONTAIN IT. THE CATALOG CONTAINS A TRANSPARENT DRESSING, NOT A BRAND NAME, WHICH CAN BE CONSIDERED EQUIVALENT TO THE BRAND TEGADERM. UPON RECEIVING THE NOTIFICATION, AN ASSESSMENT ON WHETHER NOTIFICATION TO THE FDA SHOULD BE COMPLETED WAS CONDUCTED ON (B)(6) 2024. BASED ON THE ASSESSMENT, IT WAS CONCLUDED THAT NOTIFICATION WAS NOT NECESSARY CONSIDERING THE FOLLOWING: WHILE THERE WERE ALLERGIC REACTIONS REPORTED, THERE IS NO INDICATION OF INFECTION OR OTHER SERIOUS REACTIONS, AND THE SYMPTOMS WERE LIMITED TO ALLERGIC REACTIONS. THIS DOES NOT SUGGEST AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO PUBLIC HEALTH. HOWEVER, FURTHER INVESTIGATION IS TO BE CONDUCTED TO DETERMINE IF ANY ACTION IS REQUIRED. THE REACTIONS DESCRIBED WERE ALLERGIC IN NATURE AND DO NOT APPEAR TO INVOLVE LIFE-THREATENING CONDITIONS OR RESULT IN PERMANENT IMPAIRMENT OR DAMAGE TO BODILY STRUCTURE. ADDITIONALLY, THERE WAS NO MENTION OF IMMEDIATE MEDICAL INTERVENTION TO MANAGE THE REACTIONS. THE REPORT DESCRIBES ALLERGIC REACTIONS, NOT A DEVICE MALFUNCTION. THERE IS NO INDICATION THAT THE PRODUCT MALFUNCTIONED IN A WAY THAT WOULD CAUSE DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THE REACTIONS ARE RELATED TO SKIN SENSITIVITY RATHER THAN A FAILURE OF THE PRODUCT'S INTENDED FUNCTION. BASED ON INFORMATION CURRENTLY AVAILABLE, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THIS POSES A BROADER SAFETY RISK. SINCE ALLERGIC REACTIONS WERE NOT REPORTED TO HAVE BEEN LIFE-THREATENING, THERE IS NO INDICATION OF SERIOUS INJURY OR MALFUNCTION. THE INVESTIGATION IS ONGOING, AND THE DECISION MAY BE REASSESSED AS ADDITIONAL INFORMATION BECOMES AVAILABLE. NONETHELESS, AS THE REPORT NOTED DIRECT PATIENT INVOLVEMENT, ALL STAFF AT BHD WERE INSTRUCTED TO CONDUCT ACTIVITIES AND PROVIDE RESULTS AS SOON AS POSSIBLE. TREND ANALYSIS ((B)(6) 2024) - A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS REGARDING THE TRANSPARENT DRESSING. THE SAME RESULT WAS FOUND IN THE CPAR DATA. INSPECTION ((B)(6) 2024) - THE REPORTED LOT OF THE TRANSPARENT DRESSING WAS NO LONGER AVAILABLE IN STOCK; NONETHELESS, THE AVAILABLE STOCK WAS INSPECTED AND FOUND ACCEPTABLE ACCORDING TO BHD QUALITY STANDARD REQUIREMENTS. INVESTIGATION ((B)(6) 2024) - IT WAS CONFIRMED THAT THE PRODUCT UNDERWENT ALL STAGES WITHOUT ANY NONCONFORMANCES IDENTIFIED. A REVIEW OF REJECTION DATA DID NOT IDENTIFY ANY RELATED REJECTIONS FOR THE PART. VENDOR CONTACT & RESPONSE ((B)(6) 2024) - THE VENDOR CONFIRMED THAT THERE HAVE BEEN NO CHANGES TO THE PRODUCT AND PROVIDED PROOF OF SKIN SENSITIZATION TESTING, WITH PASSING RESULTS. FURTHERMORE, QUESTIONS WERE EMAILED TO THE REPORTER THROUGH THE SALES REPRESENTATIVE ON (B)(6) 2024 TO GATHER MORE INFORMATION. THE QUESTIONS WERE AS FOLLOWS: CAN YOU PROVIDE MORE DETAILS ON THE NATURE OF THE ALLERGIC REACTION? (E.G., TYPE OF SYMPTOMS, SEVERITY, HOW LONG AFTER THE APPLICATION THE REACTION OCCURRED, ETC.) A. ARE THERE ANY PICTURES OF THE ALLERGIC REACTIONS? WERE THE PATIENTS WHO EXPERIENCED THE REACTION PART OF A SPECIFIC DEMOGRAPHIC (AGE, MEDICAL CONDITION, MEDICATION USE, ETC.)? A. WAS THIS THEIR FIRST TIME HAVING THE PROCEDURE PERFORMED? DO ANY OF THE AFFECTED PATIENTS HAVE A KNOWN HISTORY OF ALLERGIES, PARTICULARLY TO ADHESIVES OR MEDICAL DRESSINGS? WERE ANY TREATMENTS ADMINISTERED TO THE PATIENTS FOLLOWING THE ALLERGIC REACTION? IF SO, WHAT WAS THE OUTCOME OF THE TREATMENT? DID SIGNATURE WELLNESS SUBMIT MEDWATCH TO THE FDA FOR THIS? IF SO, COULD WE PLEASE HAVE A COPY? THE FOLLOWING RESPONSES WERE PROVIDED ON (B)(6) 2023: WE TYPICALLY TELL OUR PATIENTS TO KEEP THE DRESSING ON FOR 24 HOURS. TYPES OF REACTIONS HAVE RANGED FROM GENERAL ERYTHEMA TO BLISTERING (ONE PATIENT NOW HAS A SCAR). THE ERYTHEMA AND BLISTERING ARE EXACTLY THE OUTLINE OF WHERE THE TEGADERM WAS APPLIED. SOME HAD REACTIONS FOR OVER A WEEK, BUT MOST RESOLVED. A. THERE ARE A FEW PICTURES, BUT WE WOULD NEED PATIENT PERMISSION TO SHARE THEM SINCE THEY SUBMITTED THEM. THE MAJORITY OF OUR PATIENTS ARE PERIMENOPAUSAL/MENOPAUSAL, AND WE HAVE SEEN REACTIONS ACROSS ALL ETHNICITIES, FROM CAUCASIAN TO AFRICAN AMERICAN. ALL PATIENTS ARE PELLET PATIENTS; WE USE ANAZAO PELLETS, BUT THE LOT NUMBERS AND DOSING DIFFER FOR EACH PATIENT. A. NONE OF THESE PATIENTS HAVE HAD REACTIONS IN THE PAST, AND IT WAS NOT THEIR FIRST TIME. WE HAVE ONLY USED YOUR PRODUCTS. NONE HAD EXPERIENCED ALLERGIES TO ADHESIVES IN THE PAST. WE TYPICALLY RECOMMEND ANTIHISTAMINES AND, IF NEEDED, 1% HYDROCORTISONE CREAM, WHICH USUALLY RESOLVES THE PROBLEM; HOWEVER, SOME HAVE HAD ISSUES FOR UP TO A WEEK, AND ONE PATIENT HAD SCARRING. NOTHING HAS BEEN SUBMITTED AS OF NOW BECAUSE WE WANTED TO CHECK IF ANYTHING CHANGED ON YOUR END. ON (B)(6), A MEETING WAS HELD WITH MANAGEMENT TO REVIEW ALL THE INFORMATION AVAILABLE THUS FAR. MANAGEMENT CONCLUDED THAT THERE IS STILL NOT ENOUGH INFORMATION TO MAKE A DEFINITIVE CONCLUSION; HOWEVER, BASED ON THE RESPONSES FROM THE USER, A MEDWATCH SHOULD BE SUBMITTED FOR THE FOLLOWING REASONS: TYPE AND SEVERITY OF REACTIONS: THE PATIENTS HAVE REPORTED A SPECTRUM OF REACTIONS, INCLUDING ERYTHEMA, BLISTERING, AND SCARRING. THE NATURE OF THESE REACTIONS MIRRORING THE OUTLINE OF THE TRANSPARENT DRESSING MAY SUGGEST A DIRECT CORRELATION BETWEEN THE PRODUCT AND THE ALLERGIC RESPONSES. GIVEN THAT THE PATIENTS HAVE NOT EXPERIENCED THIS BEFORE, THIS RAISES SIGNIFICANT CONCERNS ABOUT THE PRODUCT. LACK OF PREVIOUS REACTIONS: NOTABLY, NONE OF THE PATIENTS HAD REPORTED ALLERGIES TO THE DRESSING OR ADHESIVE BEFORE, COMPLICATING OUR UNDERSTANDING OF THESE REACTIONS. GIVEN THEIR PREVIOUS TOLERANCE, THE SUDDEN REACTIONS MAY SUGGEST CHANGES TO THE PRODUCT, WHICH SHOULD BE FURTHER REVIEWED IN THE INVESTIGATION. ABSENCE OF PRIOR HISTORY: SINCE THIS IS THE FIRST REPORT OF SUCH REACTIONS AND NO PREVIOUS INCIDENTS HAVE BEEN RECORDED, THIS WARRANTS FURTHER INVESTIGATION.
THE ORIGINAL SUBMISSION ON (B)(6) 2024 CHECKED BOTH 5-DAY REPORT AND AN INITIAL REPORT. THE SUBMISSION SHOULD HAVE ONLY NOTED AN INITIAL REPORT. SECTION G6 HAS BEEN CORRECTED UNDER THIS SUBMISSION.
A CLINICIAN/END-USER REPORTED THAT A PATIENT DEVELOPED A RASH AFTER USING THE PELLET INSERTION TRAY DURING THE PROCEDURE. THE REACTION WAS DIRECTLY LINKED TO THE TRANSPARENT DRESSING COMPONENT INCLUDED IN THE KIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602503 | 3.2MM PELLET INSERTION TRAY #2 - STERILE / LATEX FREE | 3.2MM PELLET INSERTION TRAY #2 - STERILE / LATEX FREE | FBQ | 75 ARKAY DRIVE | S10588 | 20220514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |