MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE BIOGEL PI ORTHOPRO SZ 8.0

Catalog Number 47680

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2014

Event Type  Injury  

Event Description

(b)(4).Received e-mail from facility stating that the glove ruptured.No samples collected.Unable to collect further info from facility.

Manufacturer Narrative

(b)(4).

• Brand Name: BIOGEL PI ORTHOPRO SZ 8.0
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE; norcross GA
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 6782507912
• MDR Report Key: 4223532
• MDR Text Key: 5077844
• Report Number: 3004763499-2014-00018
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47680
• Device Lot Number: 123 B327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other