MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; APPARATUS, AUTOTRANSFUSION

Catalog Number UNK_IPR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Brain Injury (2219)

Event Date 08/08/2010

Event Type  Injury  

Manufacturer Narrative

The device lot number was not provided.The product is not available for evaluation.Device is not available for evaluation.

Event Description

On or about (b)(6) 2010, the patient underwent bilateral knee surgery.It was alleged that the patient received 2 cbcii constavac systems for wound drainage.It was alleged that the patient sustained brain damage following the surgery.There are no allegations that the product failed to perform as designed.Stryker is unable to ascertain whether or not one of its products was actually used and will not be able to obtain the product except within the litigation process, if at all.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5101079
• MDR Text Key: 26662384
• Report Number: 0001811755-2015-03539
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Report Date: 07/07/2015

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: Health Professional
• Device Catalogue Number: UNK_IPR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• 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