MAUDE Adverse Event Report: CAPITAL BEDDING 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268; COVER, MATTRESS (MEDICAL PURPOSES)

Model Number NA:5185

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The mattress was not returned to invacare, but a picture was received.Based on the picture provided by the reporter, the alleged issue of there being an unfinished curled spring coming out of the mattress could not be confirmed.The caller has not responded to repeated attempts to get more information concerning the injury, treatment, and the incident in general.Invacare is filing this report in an abundance of caution.Should additional information become available, a supplemental record will be filed.

Event Description

Invacare received the following complaint: the caregiver alleges while attempting to make the bed using a fitted sheet, her hand caught on an unfinished curled spring on the 5185 mattress.She sustained a 1¿ laceration to her left palm which required sutures.

• Brand Name: 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268
• Type of Device: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): CAPITAL BEDDING; 5262 raymond ave; verona MS 38879
• MDR Report Key: 8628833
• MDR Text Key: 145676671
• Report Number: 1531186-2019-00004
• Device Sequence Number: 1
• Product Code: FMW
• 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: Other
• Type of Report: Initial
• Report Date: 05/21/2019,04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA:5185
• Device Catalogue Number: 5185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2019
• Date Manufacturer Received: 04/22/2019
• 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
• Patient Outcome(s): Required Intervention