MAUDE Adverse Event Report: WELCH ALLYN, INC. CUFF, WA, REUSABLE, LG ADULT; BLOOD PRESSURE CUFF

Model Number	REUSE-12
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A nurse with a known severe allergy to latex alleged that when she attempted to take a blood pressure on a patient, she placed the cuff on the patient¿s arm, and when she grabbed the durashock manual gauge (bulb), she immediately started having respiratory symptoms that rapidly progressed to anaphylactic shock.Emergency treatment included: two rounds of epinephrine, one round of solu-medrol, benadryl both intravenous and sublingual, and an albuterol respiratory treatment.The customer received emergency medical treatment in the medical office and refused transport to the hospital.She has recovered from the incident.Anaphylaxis is serious medical emergency and therefore meets the criteria of a reportable event.Investigation of this event is ongoing.Per the device design files, the durashock bulbs, tubing and cuffs are manufactured without latex.The device is being returned to welch allyn for investigation.No further information is available on the evaluation of the device at this time.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Hillrom/welch allyn received a report from the account stating an employee came into contact with a welch allyn pss-44 durashock with reuse-12 blood pressure cuff and had anaphylactic shock, compromised airway and rash after coming into contact with the device.The employee was emergently treated at the account's location (medical clinic) and refused transport to the hospital.The employee has recovered from the incident.The device was located at the account at the time of the event.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: CUFF, WA, REUSABLE, LG ADULT
• Common Device Name: BLOOD PRESSURE CUFF
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street; skaneateles falls NY 13153 0220
• MDR Report Key: 9775386
• Report Number: 1316463-2020-00001
• Device Sequence Number: 16601287
• Product Code: DXQ
• UDI-Device Identifier: 00732094066708
• UDI-Public: 732094066708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: REUSE-12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening