MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH, UNKNOWN SIZE/PRODUCT ID; ANTIMICROBIAL PRODUCTS

Catalog Number XXX-BIOPATCH

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Journal of hospital infection 96 (2017) published: "chlorhexidine gluconate or polyhexamethylene biguanide disc dressing to reduce the incidence of central-line-associated bloodstream infection: a feasibility randomized controlled trial (the clabsi trial)" the aim of this study was to investigate the feasibility and safety of comparing two antimicrobial-impregnated discs to prevent central-line associated bloodstream infection (clabsi).A single-centre, parallel group randomized controlled trial was conducted in a 929-bed tertiary referral hospital.One hundred hospital inpatients requiring a peripherally inserted central catheter were randomized to chlorhexidine gluconate (chg) (biopatch: n=49; 26 females, 23 males; mean age 60.65+/-15.78 years; mean weight 88+/-23.21) or polyhexamethylene biguanide (phmb: n=51) disc dressing group.One rash, in the shape of the chg disc dressing, was the only study disc-related event.The rash had resolved by the next two-day check and the picc was removed shortly after, as treatment had been completed.".

Manufacturer Narrative

Integra has completed their internal investigation on january 19, 2018.Results: no sample will be returned for evaluation since units involved in the reported incident were used during a medical study performed during undetermined period and are not available.In addition, no pictures of skin condition were provided; therefore, the event/condition could not be confirmed.Dhr review; could not be performed since no catalog /lot number was reported.Complaints history; upon review of integra's complaint system from december 2015 ¿ january 2018, five complaints, including the one being investigated throughout this report, related or categorized under specifically the term ¿rash¿ were evaluated for biopatch product family.Nonetheless, it was taking into consideration similar complaints related to skin irritation and/or adverse reaction.It was found that a total of 43 complaints for biopatch product family were evaluated for these conditions.(b)(4).Conclusion: no assignable cause that could be associated to the manufacturing process of biopatch was identified.However, biopatch¿s ifu literature recognizes the possibility of an adverse reaction.The ifu warns: ¿ ¿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.¿.

• Brand Name: BIOPATCH, UNKNOWN SIZE/PRODUCT ID
• Type of Device: ANTIMICROBIAL PRODUCTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7143145
• MDR Text Key: 95726636
• Report Number: 2648988-2017-00063
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K003229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BIOPATCH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other