MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 2.5GRAMS; WAX, BONE

Catalog Number W31C

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device am1791 number, and no non-conformances were identified.The photo 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.

Event Description

It was reported that the product was received on unknown date and not used on the patient.The problems with product packaging was noticed.The box has different markings.The box says "wax".The instruction applies to needles.No patient consequence reported.

Manufacturer Narrative

(b)(4).Additional h3 investigation summary: it was reported packaging labeling identification.During visual inspection of five pictures, four photos showed a sealed box of product code w31c, lot am1791 with a re-packed in asiatic idiom and the only we can distinguish the word in parentheses (vicryl plus).In the fifth picture only could be observe two sealed boxes of product code w31c, lot al9564, no relabel was noted.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the picture, the complaint was manufacturing packaging labeling defect.

• Brand Name: BONE WAX 12 X 2.5GRAMS
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9805880
• MDR Text Key: 197961970
• Report Number: 2210968-2020-01834
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W31C
• Device Lot Number: AM1791
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 04/09/2020
• Patient Sequence Number: 1