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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MCKESSON PSS C3 5-0 UBR PGA 18"/46CM

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SURGICAL SPECIALTIES CORPORATION MCKESSON PSS C3 5-0 UBR PGA 18"/46CM Back to Search Results
Model Number SJ493G
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Cyst(s) (1800); Purulent Discharge (1812); Erythema (1840); High Blood Pressure/ Hypertension (1908)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
Method: the actual product involved with the incident was discarded. No samples or photos were returned for evaluation to date. Results/conclusions: no samples were returned for review. Relevant portions of the device history record were reviewed. The product from this finished good lot and all of the component lots met current usp and surgical specialties mexico inc. Requirements throughout the incoming, manufacturing and the final inspection processes. No inventory is available for the finished good lot reported. Without receiving samples to review/test, receiving detailed information regarding the surgeon's technique, material placement in tissue, pre-operative instructions or events a definitive root cause for the partial dehiscence cannot be determined with certainty. Infection was mentioned. However, no details or culture results were received to confirm this report. (b)(4). Item #sj493g mckesson pss 5-0 undyed pga 18" c3, lot mdlf410 (reading).
 
Event Description
An epidermal cyst was fully excised on a patient with hypertention, dm, hyperlipidemia. When patient returned to have sutures removed, there was a yellow discharge from one corner of the wound and circumferential erythema. This persisted until sutures were removed. Wound dehiscence from the inside was noted. Pieces of suture were removed from the deep dermal tissue. No additional details were disclosed.
 
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Brand NameMCKESSON
Type of DevicePSS C3 5-0 UBR PGA 18"/46CM
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key6991868
MDR Text Key90737168
Report Number3010692967-2017-00007
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K965162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2020
Device Model NumberSJ493G
Device Catalogue NumberSJ493G
Device Lot NumberMDLF410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
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