MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS SCD SLEEVES; STRYKER SCD SLEEVES

Model Number RCG10

Device Problem Air Leak (1008)

Patient Problems Bruise/Contusion (1754); Edema (1820); Erythema (1840)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

We had an issue with our scd sleeves causing an injury to this patient.There was significant (+2/+3) edema noted above and below scd placement, but no edema noted where scds were applied.There was also some bruising and redness noted to areas where scds were applied.The company representative visited and investigated our product.He found the product had a chamber that fills with air but it will not release the air.The sleeves identified with that lot number have been pulled off the shelf and stryker is replacing them.Stryker is doing an investigation on those sleeves prior to issuing a recall.

• Brand Name: SCD SLEEVES
• Type of Device: STRYKER SCD SLEEVES
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85238
• MDR Report Key: 7366060
• MDR Text Key: 103425492
• Report Number: MW5076053
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RCG10
• Device Lot Number: D171473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR