MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED CLEARASIL ULTRA OVERNIGHT SPOT PATCHES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Tissue Damage (2104)

Event Date 03/07/2020

Event Type  Injury  

Event Description

(b)(6) for (b)(6) [staphylococcal infection].Patient's breast became enlarged [breast enlargement].Patient had small grade fever [pyrexia].Irritation spread larger and became purple in colour [skin discolouration].Patient felt some skin layers pull off [application site laceration] irritation [skin irritation].Pain [pain].Redness [erythema].Case description: initial report, date 01-may-2020.Received from consumer relations, country united states, reference no: (b)(4).Suspect product: clearasil ultra overnight spot patches.Batch no and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6).It was reported that on (b)(6) 2020, a (b)(6) old female patient used clearasil ultra overnight spot patches.Patient stated that a little while prior to reporting, she had tried for the first time one of these clearasil ultra overnight patches on a blemish on her face and she stated that the patch worked well to remove that blemish so she decided to try this overnight patch under her left breast where she had a little bump but not yet a full pimple.She followed the directions and cleaned off the area and placed the patch on this bump and went to bed.The next day she took the patch off and she stated it felt like she might have taken some layers of skin off because she did state that the patches are very sticky.She did not pay much mind to it and she then took a shower.The next morning the area was red and she was experiencing also a low grade fever.She thought it was unusual, so she marked the edges.She decided to trace the redness with a sharpie marker to keep track of the irritation in case this irritation would spread.The next day the irritation spread larger and became purple in colour and she was still experiencing a low grade fever.At this point the patient went to the emergency room where they tested the area and started her on antibiotics.The patient's breast became enlarged, twice the size it normally was.She was sent by ambulance to a bigger hospital on (b)(6) 2020 where she was admitted for 5 days.She arrived at night and began different antibiotics.This hospital tried to drain the area but they were not successful in draining the area and continued to administer antibiotics, vancomycin unknown, intravenously into her but the antibiotic was not working.On (b)(6) 2020, the surgeon performed emergency surgery to drain the area and had cut 3 large incisions 2 inches long in a triangular form.On the 4th day of being admitted to the hospital the tests had come back positive for mrsa and she was immediately moved into isolation in the infections area of the hospital.The doctor had stated to her that she did remove several layers of her skin when removing the patch and caused that area to be infected.It moved up and filled her left breast with the infection.Patient stated that she was in a lot of pain and was given pain killers in the hospital.She went home on (b)(6) 2020 with drains and a pic line attached to her administering antibiotics into her body.She had to have the drains inserted into her body for 3 weeks and the pic lines for 2 weeks after she returned home.She had a home nurse for 7 weeks and yesterday (on (b)(6) 2020) was when the nurse was discharged because she was all healed that day (on (b)(6) 2020).She had her last iv home treatment and nurse visit last week.She stated she was allergic to penicillin and therefore was not given penicillin for this reaction she experienced.She stated that this reaction she experienced still seems so surreal.She also stated that she was in good health and did take any medications and mentioned that her immune system has never been compromised.She did not have the box of patches anymore.Patient also stated that she used the product once and the injury occurred within 24 hours.She had used the product before but had not used any other products in the range.Patient did not suffer from any skin allergies or eczema at the time of reporting.The patient was admitted to hospital for 5 days, admittance date (b)(6) 2020 and discharge date (b)(6) 2020.This case has been deemed serious due to hospitalisation.Follow up has been requested to obtain further information.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: recovered / resolved.

• Brand Name: CLEARASIL ULTRA OVERNIGHT SPOT PATCHES
• Type of Device: CLEARASIL ULTRA OVERNIGHT SPOT PATCHES
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, united kingdom HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 10058430
• MDR Text Key: 198896798
• Report Number: 3000719502-2020-00011
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/01/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 38 YR