MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; SHOULDER W/POUCH II

Model Number	DYNJS0841
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received from rn administrator, (b)(4) ambulatory surgery center (b)(4) with additional information related to this reported incident.Reporter informs, that end user/patient had right shoulder arthroscopy, (b)(6) 2020.End user is reported to have allergies to latex and sensitivity to tape.End user has had two other reported similar procedures,(b)(6) 2016 left shoulder scope, no issues and (b)(6) 2020, right shoulder scope with capsular release without incident.Reporter states, during the procedure on (b)(6) 2020 end user experienced a reaction to the adhesive from the u-drapes upon removal of the adhesive from underneath her right axilla patient expressed pain and had a blister.Reporter states, end-user had multiple follow-up visits with the physician (dates unknown), and states the blister, redness and patient's reports of pain were present for several weeks.Reporter states, end user was prescribed a prednisolone cream.End-user is reported to be "having no issues." reporter states, there are no samples available for return and evaluation.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Investigation results: trending: trending was reviewed and there have been 1 additional reported complaint(s) for this issue in the past 6 months.Investigation summary: the account reported finding reaction from adhesive on drape.The reported issue occurred in item dynjs0841 (lot unknown).Based on the information provided, we are unable to confirm the reported issue without a photo or sample provided.
Event or Problem Description
It was reported, "a patient had a shoulder procedure done last week with a severe skin reaction, with wounds appearing like burns.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: SHOULDER W/POUCH II
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11057961
• Report Number: 1423395-2020-00047
• Device Sequence Number: 3206531
• Product Code: OJH
• UDI-Device Identifier: 10080196597567
• UDI-Public: 10080196597567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJS0841
• Device Catalogue Number: DYNJS0841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/22/2020
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 66