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

Model Number 4901730021913

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

Patient Problems Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/27/2021

Event Type  Injury  

Event Description

It was reported that, the consumer was injured on (b)(6) 2021, saw an orthopedic surgeon on (b)(6) 2021 and was applied a tape for which a material similar to band aid brand kizu power pad (kpp).Due to a large amount of exudate, the tape applied at the orthopedic surgeon came off, and the consumer used one strip of kpp on (b)(6) 2021.On (b)(6) 2021, the consumer saw the orthopedic surgeon and was applied another tape for which a material similar to kpp again.Consumer felt like it was not getting better because the exudate leaked from the tape, but since the hospital was closed, he/she persevered.On (b)(6) 2022, consumer went to see a surgeon, who told consumer that when the wound was deep the fluid-absorbing tape would not improve wound, and consumer was disinfected or treated around the affected area, then the affected area was getting slightly better.Seeing the physician was scheduled again on (b)(6) 2022.It was reported that, the kpp was only used on (b)(6) 2021, 1 strip/day.The consumer had to discontinue using the product immediately because it was flooding with fluid.At this time, this event is being reported with an overabundance of caution.Event resulted in doctor's consultation for medical treatment, but no significant intervention was reported, hence case assessed as non-serious and severity of event as minor.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, gender, weight and ethnicity were not provided for reporting.This report is for (band aid brand kizu power pad (kpp) large 6ct ap 4901730021913).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).Udi #: (b)(4), upc #: 4901730021913, expiration date: ni, lot #: 0520c.Device is not expected to be returned for manufacturer review/investigation.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).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.(b)(4).At this time, this event is being reported with an overabundance of caution.Event resulted in doctor's consultation for medical treatment, but no significant intervention was reported, hence case assessed as non-serious and severity of event as minor.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Corrected data: b4: the initial emdr was submitted with incorrect date of the awareness ((b)(6) 2021).Based on review of additional information the complaint was updated to reportable event on (b)(6) 2022.Therefore, the initial date of awareness of this complaint was (b)(6) 2022.The initial submission was submitted on-time.D3: unique device identifier (b)(4).Expiration date ¿ december 31, 2022, lot number ¿ 0520c (b)(4).H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on january 15, 2020.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13342054
• MDR Text Key: 287275708
• Report Number: 2214133-2022-00001
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(10)0520C
• 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,Followup
• Report Date: 02/14/2022

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 Expiration Date: 12/31/2022
• Device Model Number: 4901730021913
• Device Lot Number: 0520C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention