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Adverse Event Report

ETHICON, INC. SAN ANGELO COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE   back to search results
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 09/02/1994
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that the patient had a motor vehicle accident in june 1993 and developed complete impotence. Serum testosterone level was normal and patient had no other risk factors for impotence. In 1994 patient underwent implant of inflatable pentile implant. Absorbable suture was used to close the scrotum. Post op, about a month later, the patient presented to the e. R. With infected prosthesis and right epididymal orchitis. Temp was 101. 9, wbc was 16,900 with a shift. Sodium was 124. Patient was admitted for treatment. Patient was placed on iv primaxin and vancomycin. Patient did not respond, and the prosthetic needed to be removed. At removal the prosthetic was noted to be infected and surrounded by purulence. There was also an area of purulence near a skin suture and it was removed. Patient proceeded to heal well and was discharged on oral antibiotics in 10/1994.

 
Manufacturer Narrative

H-6 conclusion: since there is no product available for evaluation and the product lot number is unknown, the investigation of this complaint is limited and co is unable to draw conclusion. Should additional info become available a supplemental 3500a will be submitted accordingly.

 
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Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer (Section D)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer (Section G)
ETHICON, INC. SAN ANGELO
3348 pulliam st
san angelo TX 76905 4403
Manufacturer Contact
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key510884
MDR Report Key521757
Event Key495151
Report Number2210968-2004-00219
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 03/23/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/06/1994
Device Ageunknown
Event Location Unknown
Date Manufacturer Received03/23/2004
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
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/22/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ULTREX PENILE PROSTHESIS IMPLANTED 1994.,

Database last updated on January 30, 2009

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