MAUDE Adverse Event Report: Integra LifeSciences Mansfield CRYOSOLUTIONS 4PK CARTRGE; Instruments - Cryo

Catalog Number	33517
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	07/01/2026
Type of Reportable Event	Other

• Brand Name: CRYOSOLUTIONS 4PK CARTRGE
• Common Device Name: Instruments - Cryo
• Manufacturer (Section D): Integra LifeSciences Mansfield; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): Integra LifeSciences Mansfield; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50274694
• Report Number: 3014334038-2026-00062
• Device Sequence Number: 10588128
• Product Code: GEH
• UDI-Device Identifier: 10381780171966
• UDI-Public: 10381780171966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 33517
• Device Lot Number: D7149
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown