MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PROLOOP; MESH, SURGICAL, POLYMERIC

Model Number	30910
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Received report that the one of the patient labels on the package was unclear.
Additional Manufacturer Narrative
The proloop mesh was returned and evaluated to determine the cause of the complaint.Upon initial inspection, one of the five peel off labels had one digit that was very light to where it was illegible.The other four labels were very clear and legible.As there are two proloop mesh per box, the other product labels were perfect.The peel off labels are used on the patient charts and operative notes.There are a total of 5 peel off labels on every individual packaged product.The product description and product codes were accurate and legible on all labels on the returned product.A review of the device history indicates that the labels passed all requirements during the manufacture of the product.Based on the results of the investigation, manufacturing did not notice that the one peel off label did not print fully.Clinical evaluation: proloop mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.It was reported that the label on the packaging was illegible.The product has an outside label and an inside label.Even if the outer box is damaged and the label is not readable, the inner box has the label plus the ifu for the product.If the shipping box label is damaged during transport this is highly likely to be seen before opening the package.There are no clinical implications for the patient.

• Brand Name: PROLOOP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8419062
• Report Number: 3011175548-2019-00258
• Device Sequence Number: 1785802
• Product Code: FTL
• UDI-Device Identifier: 00650862309102
• UDI-Public: 00650862309102
• Combination Product (Y/N): N
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: 30910
• Device Catalogue Number: 30910
• Device Lot Number: 434291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1