MAUDE Adverse Event Report: BOSMA ENTERPRISES BIOGEL; SURGEONS GLOVES

Catalog Number 71-ML48980

Device Problems Contamination (1120); Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Technician opened a sterile pack of biogel super sensitive rubber latex surgical gloves size 8 and noted the word "sham" written in black ink.Gloves not used for procedure.

• Brand Name: BIOGEL
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): BOSMA ENTERPRISES; 6270 corporate drive; indianapolis IN 46278
• MDR Report Key: 15224402
• MDR Text Key: 297886277
• Report Number: 15224402
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 71-ML48980
• Device Lot Number: LOT 21J624
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1