MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6; PADDIE, COTTONOID

Catalog Number 24-5431

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the distributor, a 10 pack of patties contained only 9.Sample will be returned.

Manufacturer Narrative

The customer was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.Device not available.

• Brand Name: BULK SURG STRIP 1/4 X 6
• Type of Device: PADDIE, COTTONOID
• 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: 6634730
• MDR Text Key: 77518322
• Report Number: 1226348-2017-10395
• 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

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-5431
• Device Lot Number: H48436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2017
• 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