MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730021906

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

Patient Problems Erythema (1840); Pain (1994); Local Reaction (2035); Skin Discoloration (2074); Impaired Healing (2378); Numbness (2415); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.A2, a4, a5: patient age, weight, ethnicity and race were not available for reporting.D1, d2, d3, d4: this report is for one band aid brand kizu power pad (kpp) regular 10ct ap 4901730021906 4901730021906apb 4901730021906apb, lot # ni.Device is not distributed in the united states but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).D4: udi #: (b)(4).Upc #: 4901730021906 expiration date: na.Lot #: ni.D9: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.The consumer applied the product on a wound which was reportedly ¿a little deep¿ and replaced the product with a new one once every 2 to 3 days for a month and had been doing so up to the present (interpreted as misuse).On removing the product the wound was painful and the application site had become abnormally hard (coded to local reaction) and white (interpreted as application site discoloration).It was reported that ¿skin did not regenerate at the wound site¿ (interpreted as impaired healing), the ¿flesh had grown up in areas other than the wound¿ (interpreted as application site swelling).It was also reported that ¿neurological abnormalities¿ had occurred, no further details reported.The consumer consulted a dermatologist who told the consumer that the wound ¿would never heal¿ which was a futuristic statement and advised to apply ¿salicylic acid petrolatum¿ and use vitamins.No direct report of any weakness or paralysis in finger/hands nor any investigations reported.Based on limited information available, there was no direct report of any permanent impairment of function nor any limitation to activities of daily living.No hospitalization, no significant intervention reported and no other seriousness criteria met.As per follow up information received additional events ¿finger was stiff¿ (coded to health effect clinical code of musculoskeletal system), ¿looked reddish¿ (coded to erythema) noted.¿skin of the finger had less sebum¿ was subsumed under local reaction.Based on information received, ¿neurological abnormalities¿ reported earlier was interpreted to be ¿sensory nerves were numb¿ (coding updated to numbness).H6: health effect clinical codes: e2402 refers to consumer " intentional misuse/off-label use" of the product.E040203 also refers to consumer alleged about ¿site became abnormally hard subsumed the skin of finger had less sebum.¿ e171601 also refers to consumer alleged about ¿when looked at it with the naked eyes, it looked reddish¿ e1716 also refers to consumer alleged about ¿wound became abnormally white¿ e1707 also refers to consumer alleged about ¿skin did not regenerate at wound site¿ e2338 also refers to consumer alleged about ¿flesh had grown up in areas other than the wound, bulge of flesh including the area around wound¿ e0127 also refers to consumer alleged about ¿neurological abnormalities occurred, his sensory nerves were numb¿ e16 (musculoskeletal system) also refers to consumer alleged about ¿the left fourth finger was stiff¿.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A male consumer reported an event with band aid brand kizu power pad (kpp) regular.Consumer's left fourth finger was caught in a steel net and skin peeled off.On 21-sep-2023, consumer applied the device to a little deep wound after washing it with water.Consumer removed the device on the evening of the same day because the wound was so painful.After that, he replaced the device with a new one once every 2 to 3 days for a month and had been doing so up to the present.Consumer reported that his left fourth finger was stiff, painful and with redness, and sensory nerves were numb.Consumer also stated that he experienced the bulge of flesh including the area around the wound and when he looked at it with the naked eyes, it looked reddish.As consumer reported, normally, the skin would get soft after a shower, but the application site of the device became abnormally hard and white.The skin did not regenerate at the wound site, and the flesh had grown up in areas other than the wound, and neurological abnormalities (sensory nerves were numb) occurred.On (b)(6) 2023, consumer visited a dermatologist who told him that the symptom would never heal and recommended to apply salicylic acid petrolatum and a medicine to soften the skin.However, the symptoms did not improve.Consumer also visited another dermatologist and was recommended to take mecobalamin to help nerves recover, and thus he continued to take it.Currently, the redness subsided, but the skin had become hard.In addition, the consumer was having pain in his daily life as the skin of the finger had less sebum and fingerprint due to the symptom.Furthermore, the consumer suffers from a mental disorder and therefore, became depressed, and visited to a psychosomatic doctor.His left fourth finger was still abnormal as of (b)(6) 2023.

• Brand Name: BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18171966
• MDR Text Key: 328552971
• Report Number: 2214133-2023-00036
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021906
• UDI-Public: (01)4901730021906(10)NI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2023

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
• Device Model Number: 4901730021906
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male