MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ACTIVECARE +SFT SYSTEM WARNING:; SLEEVE, LIMB, COMPRESSIBLE

Model Number N/A

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Device product code: jow.

Event Description

It was reported from the patient the cord is broken and it has snapped while unplugging.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

Event Description

No additional information.

• Brand Name: ACTIVECARE +SFT SYSTEM WARNING:
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10421307
• MDR Text Key: 203864378
• Report Number: 0001526350-2020-00687
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• PMA/PMN Number: K151377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: A502B000101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1