MAUDE Adverse Event Report: ETHICON INC. SURGICEL HEMO 5X35CM; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number	1951
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: actual samples were returned for evaluation.The device received was manipulated.The pouches are not in the original sealed box.There is a "not for human use, for test only" red stamp marked on the backside of both pouches.A yellow sticker is also present on the backside of one pouch.Additional information was requested and the following was obtained: what was the lot number on the box containing these pouches with the label ¿not for human use?" "unknown can you send a picture of the box? the customer didn¿t see the box, just the packages lot number ¿ do not have.".
Event or Problem Description
It was reported that when the box arrived at the account, there were packages marked with labels stating "samples not intended for human use".No patient involvement.Additional information has been requested.

• Brand Name: SURGICEL HEMO 5X35CM
• Common Device Name: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7991896
• Report Number: 2210968-2018-76685
• Device Sequence Number: 1645307
• Product Code: LMF
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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
• Operator of Device: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 1951
• Device Lot Number: 3930519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1