MAUDE Adverse Event Report: ZHEJIANG SHUYOU SURGICAL PMI; PMI SINGLE USE REM GROUNDING PAD W/ ATTACHED CORD

Model Number	P4500
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had her skin ripped off onto the grounding pad.Patient is having to have skin grafts, donor site.They were having to.Fix the area on the patient that was damaged due to the product.Patient was 81 years old, 160 lbs, allergies to tape, latex and rubber.Pad was removed slowly, from distal end, by rn.The procedure was 198 minutes.The pad was placed on the left lateral thigh.Surgery was tissue rearrangement and site prep of perineum surgery.

• Brand Name: PMI
• Common Device Name: PMI SINGLE USE REM GROUNDING PAD W/ ATTACHED CORD
• Manufacturer (Section D): ZHEJIANG SHUYOU SURGICAL; no. 3689 yangguang av, dipu st; anji county; huzahou city, zhejiang province ; CH
• MDR Report Key: 22667992
• Report Number: 3009495876-2025-00002
• Device Sequence Number: 7486764
• Product Code: GEI
• UDI-Device Identifier: 00812608020744
• UDI-Public: 00812608020744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/30/2025
• Report Date (Section F): 07/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: P4500
• Device Catalogue Number: P4500
• Device Lot Number: 2502172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 73 KG