MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN* SURG STRIP 1/2X6 PADDIE, COTTONOID

Catalog Number 80-1451

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the lot history records did not show any anomalies during the manufacturing process. Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.

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.

Manufacturer Narrative

A partial device was returned for evaluation. Without the complete device, we were unable to confirm the issue reported by the customer or determine potential root cause. A review of manufacturing records found no discrepancies when the device was released to stock. If additional relevant information becomes available, the complaint will be reopened and a follow-up report will be submitted. Trends will be monitored for this and similar complaints. At present, we consider this report to be closed.

Manufacturer Narrative

(b)(4). Upon completion of the investigation a follow up report will be filed. A review of the lot history records did not show any anomalies during the manufacturing process.

Event Description

As reported by the rep, a 10 pack of surgical patties contained 11. There were no reports of delay or patient harm. More information is being requested.

• Type of Device: PADDIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7169430
• MDR Text Key: 273204647
• Report Number: 1226348-2018-10030
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 80-1451
• Device Lot Number: HD6262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No