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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174006
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operatively, the tacks were too embedded to remove. Patient had problems with lower legs feet, possible nerve damage, spine back problem, and walking with stoop.

 
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Brand NamePROTACK
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8505589
MDR Text Key141649659
Report Number2647580-2019-01964
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK090470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 04/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL Number174006
Device Catalogue Number174006
Device LOT NumberP4K0242X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/09/2014
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: 04/11/2019 Patient Sequence Number: 1
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