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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; PATIENT EXAMINATION GLOVE, SPECIALTY
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OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; PATIENT EXAMINATION GLOVE, SPECIALTY Back to Search Results
Model Number GLV9201
Device Problems Break (1069); Degraded (1153); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 07/23/2021
Event Type  malfunction  
Event Description
Narrative from staff: the blue medichoice pc3.5 nitrile gloves are highly degradable.There have been several occurrences along with other peers.They tear and degrade when cleaning with our facility/equipment approved cleaners.They also often break when donning/doffing.This is a hygiene issue.Manufacturer response for patient examination glove, specialty, medichoice (per site reporter): representative for owens and minor has the gloves and is investigating the issue.
 
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Brand Name
MEDICHOICE
Type of Device
PATIENT EXAMINATION GLOVE, SPECIALTY
Manufacturer (Section D)
OWENS & MINOR DISTRIBUTION, INC.
9120 lockwood blvd
mechanicsville VA 23116
MDR Report Key12301140
MDR Text Key265846461
Report Number12301140
Device Sequence Number1
Product Code LZC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGLV9201
Device Catalogue NumberGLV9201, GLV9202, GLV9203
Device Lot Number2101ABN31AA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2021
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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