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 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Device was returned for evaluation. Upon completion of the investigation a follow up report will be filed.

Manufacturer Narrative

The product was returned for evaluation. This product is documented in the ifu as low linting. While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting. Therefore lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm. Lot number not reported therefor no dhr review could be completed and tcr could not be opened. The most recent complaint and smt presentation has been reviewed and this product family did not exceed the upper control limit for complaints.

Manufacturer Narrative

(b)(4). It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.

Event Description

As reported by the distributor, surgical strips were linting.

• 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: 6763118
• MDR Text Key: 107897264
• Report Number: 1226348-2017-10539
• 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

• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 24-5432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/03/2017 Patient Sequence Number: 1