MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES, INC. CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Catalog Number CMMOD1

Device Problem Product Quality Problem (1506)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Unique complaint id # (b)(4), technician has a service visit pending to install bed straps.(bed straps are currently on back order and scheduled to arrive at site (b)(6) 2017).A follow up shall be submitted to the fda upon completion if service visit.

Event Description

Mrs.(b)(6), purchased the bed on (b)(6) 2012, the bed was delivered (b)(6) 2012.Mrs.(b)(6) states the bed straps will not stay put at the head of the base, she states she has to continue to re-attach the bed strap to the base.Mrs.(b)(6) states that in (b)(6) 2017 bases separated at the head while her husband was sleeping and when mr.(b)(4) rolled over in the bed he fell on the floor causing him to bruise himself.Mr.And mrs.(b)(6) confirm that mr.(b)(6) did not sustain any serious injury and did not seek medical attention.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6750221
• MDR Text Key: 81384027
• Report Number: 3008872045-2017-00019
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/16/2017

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: Patient Family Member or Friend
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Weight: 104