MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TENDER GRIP, SKIN FIXATION SYSTEM, ADULT -

Model Number	1005-0-25
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Left a sore when removed from babies face.Appears to have torn off layers of the babies skin.
Additional Manufacturer Narrative
The baby's skin had sores and was torn when removing skin fixation.
Additional Manufacturer Narrative
The baby's skin had sores and was torn when removing skin fixation.Complaint history reviewed.There have been 0 similar complaints in the previous 24 months for this part#.No product returned, no pictures of alleged defect.Complaint cannot be confirmed.Date of manufacture: (b)(6) 2023.No remaining product from lot# in inventory.Most likely root cause is skin sensitivity due to prolonged exposure to device.Rma-20011: r27: patient's skin is sensitive to device removal - age, medication, existing skin damage, individual patient sensitivity - s=7 o=4 rpn=28*.*to have an acceptable level of risk, rpn < 25 based on cpm, rrpn =7, which is an acceptable amount of risk.Rma will be corrected during fda remediation.
Event or Problem Description
Left a sore when removed from babies face.Appears to have torn off layers of the babies skin.

• Brand Name: SALTER LABS
• Common Device Name: TENDER GRIP, SKIN FIXATION SYSTEM, ADULT -
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17935627
• Report Number: 3000219639-2023-00032
• Device Sequence Number: 11620517
• Product Code: KGX
• UDI-Device Identifier: 00607411001024
• UDI-Public: 00607411001024
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1005-0-25
• Device Catalogue Number: 1005-0-25
• Device Lot Number: 418129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown