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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (TORRES) PROXIMATE PLUS MD SKIN STAPLER PROXIMATE SKIN STAPLER   back to search results
Catalog Number PMW55
Event Type  Injury   Patient Outcome  Other;
Event Description

It was reported that the devices were used during an unknown number of procedures. It was reported that the devices could not be utilized. Instead of fixing the skin grafts, the staples were pulling the grafts from recipient sites.

 
Manufacturer Narrative

D5, 6; h4: info is unavailable, device was not returned for eval.

 
Search Alerts/Recalls

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Brand NamePROXIMATE PLUS MD SKIN STAPLER
Type of DevicePROXIMATE SKIN STAPLER
Baseline Brand NamePROXIMATE PLUS MD SKIN STAPLER
Baseline Generic NameSKIN STAPLER
Baseline Catalogue NumberPMW55
Baseline Device FamilySKIN STAPLERS
Baseline Device 510(K) NumberK760732
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed11/03/1976
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. (TORRES)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. (TORRES)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key393047
MDR Report Key404056
Event Key381865
Report Number1527736-2002-01368
Device Sequence Number1
Product CodeGDT
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 03/01/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPMW55
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received03/01/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

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