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); Insufficient Information (3190)

Patient Problems Abscess (1690); Cellulitis (1768); Unspecified Infection (1930)

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

Thorac cardiovasc surg (2016) published " the pharyngostomy tube: indications, technique, efficacy, and safety in modern surgical practice"."this is a retrospective analysis of patients who had a pt placed from may 2005 to march 2015.A total of 84 pts were placed during the specified period.The mean patient age was 61.6+or _ 12.3 (range, 21¿86).Twenty-two (26.2%) patients were active smokers, 13 (15.5%) had a diagnosis of type 2 diabetes, and 14 (16.7%) had a body mass index (bmi)+or _ 35 kg/m2.Post-op management: the pt exit wound is treated as if it were a central line with a protective disk impregnated with chlorhexidine gluconate (biopatch), twice daily chlorhexidine gluconate oral rinse swish and spit and daily dressing changes.If there is any concern for infection (pain, erythema, fluctuation, crepitation, or frank pus secretion), the patient is placed on antibiotics that cover oral flora and the wound is closely monitored for any signs of progression to determine the need for tube removal and or drainage.A fibrous tract usually forms around the tube after 1 to 2 weeks.Results: 10 (11.2%) complications related to pt placement, including 7 cases of cellulitis treated successfully with intravenous antibiotics and 2 superficial abscesses after pt removal that required bedside drainage.".

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 nine (9) complaints for biopatch product family, including the one being investigated throughout this report, related to infection were evaluated.(b)(4).Conclusion: no assignable cause that could be associated to the manufacturing process of biopatch was identified.The condition ¿cellulitis, superficial abscesses¿ could not be confirmed.According to directions for use, the skin should be prepared prior to use and aseptic technique must be followed throughout the process.This is done following hospital protocol.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.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: 7143168
• MDR Text Key: 95903332
• Report Number: 2648988-2017-00065
• 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?: 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