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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. SHOULDER W/POUCH II Back to Search Results
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. ".

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceSHOULDER 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 Key11057961
MDR Text Key238823517
Report Number1423395-2020-00047
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received12/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJS0841
Device Catalogue NumberDYNJS0841
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/22/2020 Patient Sequence Number: 1
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