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

Model Number DYNJS0841

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blister (4537)

Event Date 06/11/2020

Event Type  malfunction  

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 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.
• Type of Device: SHOULDER W/POUCH II
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11057961
• MDR Text Key: 238823517
• Report Number: 1423395-2020-00047
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10080196597567
• UDI-Public: 10080196597567
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJS0841
• Device Catalogue Number: DYNJS0841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 66