MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP BIOPATCH 4152; DRESSING, WOUND, DRUG

Catalog Number	4152
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A healthcare professional (hcp) reported a patient experienced a severe reaction associated with the use of a biopatch (id 4152), resulting in the cancellation of surgery.It was reported that the patient had a reaction to chlorhexidine gluconate (chg) preoperatively.The hcp expressed concern that the small lettering and packaging description of the biopatch made it difficult to identify that the product contained chg, which contributed to the patient¿s reaction.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The biopatch (id 4152) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, the most probable cause for the reported event is due to the user not being familiar with product literature prior to using the product.If additional relevant information becomes available in the future, 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: BIOPATCH 4152
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08540
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22748740
• Report Number: 2648988-2025-00030
• Device Sequence Number: 15605024
• Product Code: FRO
• UDI-Device Identifier: 10705031005259
• UDI-Public: 10705031005259
• Combination Product (Y/N): Y
• PMA/510(K) Number: K003229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Catalogue Number: 4152
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown