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

Catalog Number XXX-BIOPATCH

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Skin Irritation (2076); Skin Inflammation (2443); No Code Available (3191)

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

Pediatr infect dis j (2005) published "chlorhexidine-impregnated dressing for prevention of colonization of central venous catheters in infants and children a randomized controlled study".The aim of this prospective controlled study was to determine the efficacy and safety of the chlorhexidine gluconate-impregnated sponge for the prevention of central venous catheter (cvc) colonization and cvc-associated bloodstream infection (cabsi) in infants and children undergoing cardiac surgery.The study was conducted between january 2002 and march 2003.All infants and children 0 to 18-year-old who were admitted to the pediatric cardiac icu (pcicu) during the study period and required a cvc for >48 hours were eligible to participate.145 patients were randomized by random number generator to receive a polyurethane dressing for the cvc insertion site (control group: n=71) or a chlorhexidine gluconate-impregnated sponge dressing (biopatch) covered by transparent polyurethane film (study group: n=74; 34% were male; mean age 21+/-37 months).The cvc in both groups was used for administration of fluids and medications and for drawing blood samples.Local redness developed in 4 study patients (neonates).The erythema was mild, was diagnosed as contact dermatitis and did not require a change in the dressing or removal of the cvc and resolved spontaneously after catheter removal.It is possible that the neonatal skin is more sensitive to the chlorhexidine gluconate than that of older infants and children.

Manufacturer Narrative

Integra has completed their internal investigation on january 17, 2018.Results: the units involved in the reported incident were used during the medical study performed between january 2002 and march 2003 and are not available to perform a failure analysis.Thus, the reported condition of ¿dermatitis¿ is unconfirmed.Dhr review; device history record 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 15, 2018, a total of 43 complaints (including the one under evaluation) related to ¿contact dermatitis and/ or adverse reaction¿ for biopatch product family.Eighteen (19) of these 43 complaints are related to children or babies, for which safety and effectiveness of the device has not been established as indicated in the ifu.(b)(4).Conclusion: the ifu warns: ¿ 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.Biopatch¿s ifu literature recognizes the possibility of an adverse reaction: ¿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: 7143155
• MDR Text Key: 95756590
• Report Number: 2648988-2017-00070
• 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: 11/28/2017

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?: Yes
• 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: 01/17/2018
• 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