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

Catalog Number 24-5432

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 02/07/2018

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, a 10 pk of codman1/2" x 6" patties contained 11.There were no reports of delays or patient harm.

Manufacturer Narrative

Updated udi: (b)(4).It was previously reported that the device would be made available for evaluation.Multiple attempts to obtain the device were not successful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be 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
• MDR Report Key: 7274716
• MDR Text Key: 100441562
• Report Number: 1226348-2018-10156
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: HG3103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1