MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; STAPLER,SKIN,35 WIDE,W/COUNTER,STERILE

Catalog Number STAPLER35W

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the staples, once applied to close the unidentified wounds, were easily "pulling out" of the wounds resulting in the wounds reopening after surgery.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported re-opening of wounds and in an abundance of caution, this medwatch is being filed.Companion samples were returned for evaluation and the complaint was confirmed.A root cause could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the surgical skin staples were easily "pulling out" of the wounds.

• Type of Device: STAPLER,SKIN,35 WIDE,W/COUNTER,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8304766
• MDR Text Key: 135178783
• Report Number: 1417592-2019-00011
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: STAPLER35W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other