MAUDE Adverse Event Report: BEDS BY GEORGE, INC. BEDS BY GEORGE; HAVEN

Model Number 3500

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is in response to a recent fda audit request, specifically 'observation 1' from the fda's establishment inspection report.An mdr was not originally submitted due to a mis-understanding of the requirements for reporting and because no injuries were reported or sustained in the incident.It was unknown at the time that a product malfunction without injury was sufficient to require this mdr.We have since gone back and reviewed all previous claims under the correct standard and are thus submitting this report in compliance with that standard.

Event Description

The fabric below the mesh and above the zipper on the door of a haven canopy pulled away from the seam and created a large enough opening where it is no longer appropriate to use the bed.Based on conversations with the mom, the mesh is fine, it is just the fabric that pulled away; and we determined the stich/seam that sews the fabric to the mesh is sub-standard and is thus malfunctioned allowing it to pull away/tear.Bbg processed this as a warranty and provided a new canopy at no charge under warranty.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 1045 n. nappanee st.; elkhart IN 46514
• Manufacturer (Section G): BEDS BY GEORGE, INC.; 109 14th ave; s building 2; middlebury IN 46540
• Manufacturer Contact: adam davis ; 1045 n. nappanee st.; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 8963104
• MDR Text Key: 216764926
• Report Number: 3008830652-2019-00007
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3500
• Device Catalogue Number: 3500
• Device Lot Number: ALEAH 082918
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention