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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS
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CODMAN & SHURTLEFF, INC. CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Injury (2348)
Event Date 04/29/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the perforator failed to disengage, causing a wound in the cerebral cortex and a tear of the dura matter without clinical consequences.
 
Manufacturer Narrative
Device identifier # (b)(4).Perforator was received for evaluation: dhr - there is no indication that the production process may have contributed to this complaint failure analysis - visual inspection of the returned unit found some organic matter present.Functional test of unit was found to perform as intended.The complaint could not be verified, the unit was found to meet all acceptance criteria.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
po box 16645
po box 16645
new brunswick NJ 08906
MDR Report Key10280674
MDR Text Key202591776
Report Number1226348-2020-00256
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
261221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberJ59K53
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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