MAUDE Adverse Event Report: SKLAR INSTRUMENTS ECONO STERILE¿; ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50

Model Number	96-2549
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not used on any patient.Problem noticed during incoming inspection.
Event or Problem Description
On 6/23/2025, one of sklar's distributors reached out to customer service regarding an issue with a hole in the sterile packaging of 1 ea of 96-2549 econo sterile¿ rochester-pean forceps, curved, 8 1/2" cs/50.This was noted on incoming inspection.The device was not used on any patient.

• Brand Name: ECONO STERILE¿
• Common Device Name: ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50
• Manufacturer (Section D): SKLAR INSTRUMENTS; 1333 lenape rd.; west chester PA 19382
• Manufacturer Contact: douglas kraemer ; 1333 lenape rd.; west chester, PA 19382 ; 6104303200
• MDR Report Key: 22331497
• Report Number: 2431166-2025-00007
• Device Sequence Number: 18245309
• Product Code: GEN
• UDI-Device Identifier: 10649111056802
• UDI-Public: (01)10649111056802(17)20280416(10)600032
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: Other
• Device Model Number: 96-2549
• Device Catalogue Number: 96-2549
• Device Lot Number: 600032
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown