MAUDE Adverse Event Report: ALIMED, INC. FREEGUARD; SURGEON'S GLOVES

Model Number 925923/NA/8

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

The quality issue is that the gloves were split as soon as they were taken out of the packaging.The packaging is in perfect conditions, but the gloves are split.This happened with three different pairs.We have removed the affected lot from our inventory, and we would like to return it to you for evaluation and replacement.Manufacturer response for or glove freeguard attenuation 8.0 leadfree, glove freeguard attenuation 8.0 leadfree (per site reporter): representative requested pictures, which we sent per their request.They are sending a mailer for us to return the product and will replace local stock.

• Brand Name: FREEGUARD
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ALIMED, INC.; 297 high st; dedham MA 02026
• MDR Report Key: 12376825
• MDR Text Key: 268477355
• Report Number: 12376825
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 925923/NA/8
• Device Catalogue Number: 925923/NA/8
• Device Lot Number: 0108149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1