MAUDE Adverse Event Report: PRIVATE LABEL PRODUCTS, INC. SKIN MARKER; MARKER, SKIN

Model Number	26-002
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Edema (1820); Itching Sensation (1943); Skin Irritation (2076)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating that a patient had an allergic reaction following the use of a skin marker (part 26-002, lot 45438161) in a surgery.A sample was initially reported to be available for return.However, as of the date of this report, a sample has not been returned.This product has undergone primary skin irritation and buehler sensitization testing in its final, finished form.The results for both tests met the requirements of the standard.The work order for the reported lot was reviewed for discrepancies that may have contributed to the reported issue.One defect for a dirty product was found and documented.The skin marker is supplied to deroyal by private label products.A supplier corrective action request was issued november 2, 2018, to private label products.As of the date of this report, a response has not been received.Deroyal has sold (b)(4) cases of the finished good from 2016 to 2018.Each case contains 50 each, which equates to a total of (b)(4) "eaches" sold.Internal complaints were reviewed for the same time period.No complaints were identified for the same issue that was reported in this incident.This results in a sales-to-complaint ratio of (b)(4).The investigation is ongoing at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
An end user reported an incident of allergic reaction right after surgery.A type 1 response and type 4 response were reported.
Additional Manufacturer Narrative
Root cause: the skin marker is supplied to deroyal by private label products.Therefore, a supplier corrective action request (scar) was issued to private label products.In its response, the manufacturer stated that the root cause is undetermined.The sample was received and inspected and found to be working as intended.Independently, deroyal has performed biocompatibility testing, including skin irritation and sensitization, on this product and met the requirements of the iso 10993-10 standard.Corrective action: in its scar response, private label products stated that, due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received indicating that a patient had an allergic reaction following the use of a skin marker (part 26-002, lot 45438161) in a surgery.A sample was initially reported to be available for return.The sample was returned and forwarded to the manufacturer for evaluation.This product has undergone primary skin irritation and buehler sensitization testing in its final, finished form.The results for both tests met the requirements of the standard.The deroyal complaint investigator reviewed the bioburden results for an equivalent skin marker part (the markers contain the same ink) in the most recent chamber validation and all results were found to be within the acceptable range.The work order for the reported lot was reviewed for discrepancies that may have contributed to the reported issue.One defect for a dirty product was found and documented.The skin marker is supplied to deroyal by private label products.A supplier corrective action request was issued november 2, 2018, to private label products.A response was received and accepted january 11, 2019, by deroyal personnel.Deroyal has sold (b)(4) cases of the finished good from 2016 to 2018.Each case contains 50 each, which equates to a total of (b)(4) eaches sold.Internal complaints were reviewed for the same time period.No complaints were identified for the same issue that was reported in this incident.This results in a sales-to-complaint ratio of (b)(4).The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
An end user reported an incident of allergic reaction right after surgery.A type 1 response and type 4 response were reported.

• Brand Name: SKIN MARKER
• Common Device Name: MARKER, SKIN
• Manufacturer (Section D): PRIVATE LABEL PRODUCTS, INC.; 20-21 wagaraw road; building 34; fair lawn NJ 07410
• MDR Report Key: 8116867
• Report Number: 1060680-2018-00009
• Device Sequence Number: 18915861
• Product Code: FZZ
• UDI-Device Identifier: 50749756157488
• UDI-Public: 50749756157488
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26-002
• Device Lot Number: 45438161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1