MAUDE Adverse Event Report: RICHARD ALLAN SCIENTIFIC SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE; 10% FORMALIN

Model Number 561201

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/09/2017

Event Type  Injury  

Event Description

Plantiff alleges that on or about (b)(6) 2017, she was injured when she opened an unmarked box containing a bag with "broken containers" containing and "unknown chemical".As she opened the bag, she saw the broken containers and inhaled the unknown chemical, allegedly causing her injury.She claims unspecified bodily injuries, medical expenses, lost earnings, and pain and suffering.Plainteff alleges that defendants failed to properly handle and properly label the box, which they had previously handled/transported.Respiratory impact was the only injury noted in the complaint.

• Brand Name: SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE
• Type of Device: 10% FORMALIN
• Manufacturer (Section D): RICHARD ALLAN SCIENTIFIC; 4481 campus drive; kalamazoo MI 49008
• Manufacturer (Section G): RICHARD ALLAN SCIENTIFIC; 4481 campus drive; kalamazoo MI 49008
• Manufacturer Contact: michelle bowerman ; 4481 campus drive; kalamazoo, MI 49008 ; 2695995254
• MDR Report Key: 9219024
• MDR Text Key: 163706300
• Report Number: 1831638-2019-00005
• Device Sequence Number: 1
• Product Code: IFP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 561201
• Device Catalogue Number: 561201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 12 MO
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/22/2019
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other