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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/2 X 6 COTTONOID, PADDIE Back to Search Results
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.
 
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Brand NameBULK SURG STRIP 1/2 X 6
Type of DeviceCOTTONOID, 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 Key6763118
MDR Text Key107897264
Report Number1226348-2017-10539
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880402
Number of Events Reported1
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 Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
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
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