MAUDE Adverse Event Report: STRYKER / STRYKER INSTRUMENTS ZIP 16 SURGICAL SKIN CLOSURE DEVICE (PART#: PS1160, LOT/SERIAL#: UNKNOWN); TAPE AND BANDAGE, ADHESIVE

Model Number PART NUMBER PS1160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Urticaria (2278); Discomfort (2330); Angioedema (4536); Blister (4537); Swelling/ Edema (4577)

Event Date 11/20/2020

Event Type  Injury  

Event Description

Patient had total knee replacement (b)(6) 2020, zip 16 surgical skin closure device (part#: ps1160, lot/serial#: unknown) placed.[stryker manufacturer.] zip removed (b)(6) at 2 week follow up.Reaction occurred at zip device/adhesive site on skin (b)(6) 2020.Patient with known delayed type hypersensitivity(dth) reaction to latex, documented.Would like to know if there is any latex in the adhesive or the device itself.Erythematous blistering cutaneous reaction patient suffered burning, itching, extreme pain and discomfort for 10 days.Topical corticosteroids, oral antihistamines provided no relief.Since this cutaneous contact dermatitis reaction, patient has since converted from a dth (t-cell mediated) reaction to an ige reaction foods manifested by tongue and lip swelling on several occasions, urticaria and angioedema.Upon email correspondence with (b)(4) post-market regulatory compliance senior specialist stryker (b)(4) mr (b)(4) was unwilling to provide me the antigenic components of the device and the adhesive so that i could test the patient to determine exactly to which component he is allergic in order to ensure the patient does not come into contact with this component again as it could be life-threatening should he encounter the culprit substance again.(2/2/2021) this is absurd, claiming 'proprietary' information.Fda safety report id# (b)(4).

• Brand Name: ZIP 16 SURGICAL SKIN CLOSURE DEVICE (PART#: PS1160, LOT/SERIAL#: UNKNOWN)
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): STRYKER / STRYKER INSTRUMENTS
• MDR Report Key: 11285291
• MDR Text Key: 230700975
• Report Number: MW5099228
• Device Sequence Number: 1
• Product Code: KGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PART NUMBER PS1160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 86