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

Model Number 1005-0-25

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Tears (2516)

Event Date 09/15/2023

Event Type  Injury  

Event Description

Left a sore when removed from babies face.Appears to have torn off layers of the babies skin.

Manufacturer Narrative

The baby's skin had sores and was torn when removing skin fixation.

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 Description

Left a sore when removed from babies face.Appears to have torn off layers of the babies skin.

• Brand Name: SALTER LABS
• Type of Device: 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
• MDR Text Key: 325679013
• Report Number: 3000219639-2023-00032
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00607411001024
• UDI-Public: 00607411001024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1005-0-25
• Device Catalogue Number: 1005-0-25
• Device Lot Number: 418129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other