MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GYNNIE OB-GYN STRETCHER; STRETCHER, WHEELED

Catalog Number 1061000000

Device Problem Collapse (1099)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

The patient was diagnosed with displaced fractures of the distal metaphyses of the left radius and ulna with dorsal and proximal displacement of the distal fracture fragments.The patient allegedly underwent an open reduction and internal fixation (orif) of the left wrist.Device not available.

Event Description

It was reported the patient allegedly sat on the end(foot section) of a gynnie stretcher.Its further alleged that the foot section then suddenly and unexpectedly collapsed causing the patient to fall into the floor and sustain injuries to her head, left arm, and left wrist while experiencing a loss of consciousness.

• Brand Name: GYNNIE OB-GYN STRETCHER
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 9323255
• MDR Text Key: 166594743
• Report Number: 0001831750-2019-01207
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278200
• UDI-Public: 07613327278200
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2019

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 Catalogue Number: 1061000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1