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

Catalog Number XXX-BIOPATCH

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); Itching Sensation (1943); Skin Irritation (2076); Fluid Discharge (2686)

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

The journal of heart and lung transplantation (2012) published "improving patient satisfaction in wound care of left ventricular assist device exit sites".The authors reviewed their experience with modifications on exit site dressings and application of external treatments.Thirty patients with heartware left ventricular assist devices were selected within the study group.The patients were split into 2 groups: group 1 (n=14) using a foam chlorhexidine impregnated ring (biopatch) to driveline exit site from time of implantation up to 18 months postoperative; group 2 (n=16) received an alginate gel (flaminal hydro) only dressings to exit site from implantation to 9 months post-operative.Patients in group 1 reported that whilst using the chlorhexidine ring, wounds were irritated, itchy and produced considerable exudate.Twelve of these patients found a significant improvement in the appearance and healing of their wound when changed to alginate gel.Only one positive wound culture was obtained with staph aureus, which became negative when this was repeated with alginate gel.

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, a total of 43 complaints for biopatch product family, including the one being investigated throughout this report, related to skin irritation and/or adverse reaction were evaluated.(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 and to not use product on children under 16 years of age.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.¿ ¿ the safety and effectiveness of biopatch has not been established in children under 16 years of age.

• 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: 7143144
• MDR Text Key: 95722063
• Report Number: 2648988-2017-00064
• 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