MAUDE Adverse Event Report: SCANDINAVIAN HEALTH LIMITED WHISPERJECT AUTOINJECTOR

Catalog Number 400527460

Device Problem Misfire (2532)

Patient Problems Bacterial Infection (1735); Bruise/Contusion (1754); Necrosis (1971); Scar Tissue (2060); Reaction, Injection Site (2442)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Post market.Survey report received on 25-nov-2019 (other non-e2b ref.Num.: (b)(4)).This case, received from consumer, non health pro in the united states, involved a (b)(6)-years-old female patient who reportedly experienced injection site vesicles, wound, infection, scar, device malfunction while using whisperject¿ autoinjector (medical devices).Medical history were not reported.Current condition included relapsing-remitting multiple sclerosis.The following is verbatim as provided by the patient after speaking with ms advocate: "patient states two months ago her whisperject injector misfired and it caused a blood blister the size of a tennis ball.About two weeks later she went to doctor who sent her to wound clinic.That doctor cut off top part and underneath there was a lot of black scar tissue.Doctor put on an antibiotic because of possible infection.Now the wound is the size of golf ball.Doctor was concerned that the wound was deeper than it appeared because there was no blood when he cleaned the wound." follow-up information (received 27-nov-2019): according to the patient, the whisperject would not work on (b)(6) 2019.The patient injected manually.No additional information was provided.Lot number not provided.Unknown date: the patient experienced black scar tissue(scar), possible infection(infection), the wound is the size of a golf ball(wound).Unknown date in (b)(6) 2019: the patient experienced whisperject misfired(device malfunction), two months ago her whisperjectinjector misfired and it caused a blood blister the size of a tennis ball(injection site vesicles).Action taken was unknown for medical devices.The outcome of event injection site vesicles was not recovered/not resolved, wound was not recovered/not resolved, infection was unknown, scar was unknown, device malfunction was not recovered/not resolved.Follow-up information (received 03-dec-2019): according to the patient, she began use of the whisperject in the fall of 2017 with success.On (b)(6) 2019, the whisperject reportedly felt like it fired the injection more forcefully than usual, releasing the medication too quickly into her skin on her abdomen.After the injection, consumer states she noticed a lot of bleeding at the injection site (lower abdomen) but the bleeding stopped after a little while.Consumer reports the next day she noticed bruising across her abdomen and a blood blister at the injection site.Consumer reports after about 10 days, the bruising went away but the blood blister was still there.Consumer reports two weeks after the injection, she noticed dead skin starting to slough off the blood blister and she began to use triple antibiotic ointment.Consumer states the ointment was helping, and she went to her family physician on (b)(6) 2019.The physician reportedly obtained a wound culture which showed a staph infection.Consumer states the physician prescribed amoxicillin / clavulanate 500 mg/125 mg tablets, 3 times daily for 10 days and referred her to a wound care specialist.Consumer reports on (b)(6) 2019 she saw the wound care physician, who reportedly debrided some of the dead tissue and prescribed triadhydrophilic paste and instructed her to clean the wound daily, apply the paste and cover the wound until her follow up appointment on (b)(6) 2019.The patient continues to treat her wound as instructed.The wound is reportedly is getting smaller.The patient reported the wound has a fairly large hole in the center.The skin is no longer sloughing off.The patient further described the wound as it looks like hamburger meat.The whisperject reportedly jammed during the injection on (b)(6) 2019.The whisperject reportedly was fully reset prior to use.The orange injector button was upright/released prior to firing the device.The needle depth adjuster was pushed fully on the skin.She has been unable to subsequently use the whisperject successfully.The patient reported the device is broken.The patient has been injecting manually.The following information was provided by the reporter and added to the case: laboratory data (wound culture), concomitant medication (duloxetine, alprazolam, prilosec, prozac, simvastatin, gabapentin, glatiramer, vitamin d), medical history (anxiety, gerd, hypercholesterolemia, neuropathy),whisperject start date (2017), event (revised infection to staphylococcal infection, skin necrosis, injection site bleeding, injection site bruising, device breakage), pv comment revised.See mylan related case (b)(4)(glatiramer acetate).Lot number not provided.Product return was requested.The product is currently in transit to manufacturer.Company comment: spontaneous report, serious, non-medically confirmed.The patient self-administered whisperject with glatiramer for relapsing multiple sclerosis, in an unknown time, had device issues and developed staphylococcal infection, skin necrosis, injection site vesicles, wound, scar, injection site hemorrhage and injection site bruising in the abdomen.Patient reported to healthcare facility, wound clinic, for professional treatment.Outcome not resolved.Causality related.Case considered reportable on 30 days, for potential evolution for life-threatening condition.

• Brand Name: WHISPERJECT AUTOINJECTOR
• Type of Device: WHISPERJECT AUTOINJECTOR
• Manufacturer (Section D): SCANDINAVIAN HEALTH LIMITED; 136 kuo sheng second street; taoyuan, ; TW
• MDR Report Key: 9482910
• MDR Text Key: 188594007
• Report Number: 0001110315-2019-00001
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019,12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400527460
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Distributor Facility Aware Date: 11/25/2019
• Event Location: Home
• Date Report to Manufacturer: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 104