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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH STRATAFIX PSL 0 MONODERM 60CM

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SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH STRATAFIX PSL 0 MONODERM 60CM Back to Search Results
Model Number SXMD1B102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
No samples were received for review or testing. A review of the device history record and sterilization records for this particular lot confirmed there were no quality issues noted and the devices met all specified requirements for this size/type barbed suture device. Without receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, a definitive root cause cannot be determined at this time.
 
Event Description
There were four (4) patients that had total knee replacement surgeries and were found to have infections. Two (2) patients presented with superficial infection on the skin surface. One (1) presented with deep wound infection and one (1) with a patella fracture with superficial infection on the skin surface. Three (3) were re-operated and one (1) was treated conservatively with medication. No additional details could be obtained. This particular device was utilized to close the fat/subcutaneous layer.
 
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Brand NameSTRATAFIX
Type of DevicePSL 0 MONODERM 60CM
Manufacturer (Section D)
SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH
km 0.2, bo. ensenada
rincon 00677
Manufacturer (Section G)
SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH
km 0.2, bo. ensenadak
rincon 00677
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key7795818
MDR Text Key117566874
Report Number3010692967-2018-00016
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
PMA/PMN Number
K072028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,08/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Model NumberSXMD1B102
Device Catalogue NumberSXMD1B102
Device Lot NumberMDVR570
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date06/13/2018
Device Age17 MO
Event Location Home
Date Report to Manufacturer07/19/2018
Date Manufacturer Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/18/2018 Patient Sequence Number: 1
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