MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION BIOPATCH 4150

Catalog Number	4150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation and no pictures showing the condition were provided by the customer.Based on the information provided by the customer, the possible root cause for ¿blisters and rash¿ is device used on patient with material sensitivity.However, the biopatch¿s instructions for use (ifu) literature recognizes the possibility of adverse reactions: ¿adverse reactions to chlorhexidine gluconate such as dermatitis, hypersensitivity, and generalized allergic reactions are very rare, but if any such reactions occur, discontinue use of the dressing immediately.¿ per directions for use, the skin should be prepared prior use and aseptic technique must be followed throughout the process.It is also important to change the dressing ¿at a minimum of 7 days although changes will be needed more frequently with highly exuding wounds¿.Patient age was not disclosed, nonetheless it is important to consider the following warns included in the ifu: do not use biopatch on premature infants.Use of this product on premature infants has resulted in hypersensitivity reactions and necrosis of the skin.The safety and effectiveness of biopatch has not been established in children under 16 years of age.
Event or Problem Description
Medwtach report mw5101027: patient's mom reports that her child is having blisters/rash underneath central line dressing and biopatch.It is not warm to the touch or oozing.No additional information was provided.

• Brand Name: BIOPATCH 4150
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• MDR Report Key: 12264541
• Report Number: 1121308-2021-00030
• Device Sequence Number: 16258469
• Product Code: FRO
• Combination Product (Y/N): N
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

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: 4150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1