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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE

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ETHICON, INC. COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE Back to Search Results
Lot Number BM2HCPM0
Device Problem Absorption
Event Date 03/12/2010
Event Type  Injury  
Event Description

It was reported that a patient underwent a surgical procedure on an unknown date and suture was used. The suture remained intact in the patient for more than two weeks and had to be removed due to irritation. Additional information had been requested.

 
Manufacturer Narrative

(b) (4). (b) (4). Conclusion: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

 
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Brand NameCOATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Manufacturer (Section D)
ETHICON, INC.
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON. SAS AUNEAU
neuily sur seine
auneau
FR 
Manufacturer Contact
krystina laguna
route 22 west
p.o. box 151
somerville , NJ 08876-0151
9082183043
MDR Report Key1693964
Report Number2210968-2010-00522
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT NumberBM2HCPM0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/04/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Other
Date Manufacturer Received04/14/2010
Was Device Evaluated By Manufacturer? No
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: 05/17/2010 Patient Sequence Number: 1
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