MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/2 X 6; COTTONOID, PADDIE

Catalog Number 24-5432

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the distributor, surgical strips were linting.

Manufacturer Narrative

It appears that this product was lost in shipping, not returned to the codman complaints department.Therefore, this complaint will be closed, should the product be found/returned to the complaints department the complaint will be re-opened and an investigation will be performed.At the present time this complaint is now closed.

• Brand Name: BULK SURG STRIP 1/2 X 6
• Type of Device: COTTONOID, PADDIE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6904225
• MDR Text Key: 87770102
• Report Number: 1226348-2017-10715
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 24-5432
• Device Lot Number: H43058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 10/19/2017
• 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: Initial
• Patient Sequence Number: 1