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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 1X3 PATTIE, COTTONOID

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CODMAN & SHURTLEFF, INC. BULK SURG PAT 1X3 PATTIE, COTTONOID Back to Search Results
Catalog Number 24-5412
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It has been reported that the device will not be returned for evaluation. A lot number has been provided. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, there was an incorrect number of surgical patties in a packet. There were no reports of delay or patient harm.
 
Manufacturer Narrative
Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. The manufacturing records were reviewed, and no anomalies were found. 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 NameBULK SURG PAT 1X3
Type of DevicePATTIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key7848027
MDR Text Key119660004
Report Number1226348-2018-10635
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 distributor
Type of Report Initial,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5412
Device Lot NumberHT2029
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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