MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP; M3-DERMAL

Catalog Number	33510
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that on two different occasions, the physician was unable to screw the cartridges/cryosolutions set with 1 cartridge/1mm tip (33510) in quickly enough.In the same instances, they both completely emptied before she was able to get them attached successfully".It was reported that when the physician tried to attach the second cartridge, it "malfunctioned and leaked causing a burn on her finger".It was reported that the "procedure was not performed.Device malfunctioned prior to procedure initiation".The patient was reportedly "unharmed/not involved in the incident".
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The suspected cryosolutions set with 1 cartridge/1mm tip (33510) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Investigation by the product legal manufacturer/sales entity, found that certain lots or cryosolutions cartridges lots were affected by a valve that may open prematurely.The legal manufacturer has provided a safety advisory and instructions for use (ifu) updates which have been distributed by integra to affected customers/distributors as part of a voluntary correction.The serial number of the device and the lot number of the cartridges involved in this incident were not provided by the customer; however, it is indicated that the customer received the safety advisory and therefore received the affected lots.Without return of the product for evaluation, a definitive root cause of the reported complaint cannot be determined.If additional relevant information becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP
• Common Device Name: M3-DERMAL
• 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 ; 6099362319
• MDR Report Key: 22010319
• Report Number: 3014334038-2025-00059
• Device Sequence Number: 12097997
• Product Code: GEH
• UDI-Device Identifier: 10381780171898
• UDI-Public: 10381780171898
• Combination Product (Y/N): N
• PMA/510(K) Number: K091721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 33510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT AVAILABLE/CORRECTION
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown