MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE, US LLC BIOGEL INDICATOR UNDERGLOVE; SURGEON'S GLOVE

Catalog Number REF 31275

Device Problems Material Puncture/Hole (1504); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Multiple occurrences of defect in sterile 7.5 biogel green underglove (ref (b)(4)).Finger on right glove folded over and when staff attempts to unfold it the glove rips and causes a hole.Latest defect is lot 21/029.Fda safety report id# (b)(4).

• Brand Name: BIOGEL INDICATOR UNDERGLOVE
• Type of Device: SURGEON'S GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE, US LLC; norcross GA 30092
• MDR Report Key: 13118608
• MDR Text Key: 283137773
• Report Number: MW5106379
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 31275
• Device Lot Number: 210 1029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1