MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITAGEL 4.5ML

Catalog Number 2113-0000

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 03/07/2014

Event Type  Injury  

Event Description

It was reported that a patient developed a 11cm hematoma following a nephrectomy case where vitagel was applied.

Manufacturer Narrative

Three attempts were made by phone call to the surgeon on (b)(4) 2014 to obtain more information to evaluate the reported event; the surgeon has not responded.A letter was sent on (b)(4) 2014, notifying the surgeon that the complain will be closed without further information to evaluate the reported event.Device not returned, lot specific information was not provided.

• Brand Name: VITAGEL 4.5ML
• Type of Device: VITAGEL
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: jeremy apelian ; 45 great valley parkway; malvern, PA 19355 ; 6104075257
• MDR Report Key: 3714327
• MDR Text Key: 4268871
• Report Number: 0002530131-2014-00002
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2113-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other