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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 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.
 
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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 Key7274716
MDR Text Key100441562
Report Number1226348-2018-10156
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
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 Number24-5432
Device Lot NumberHG3103
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/13/2018
Initial Date FDA Received02/15/2018
Supplement Dates Manufacturer Received03/19/2018
Supplement Dates FDA Received03/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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