SURGEONS HOOD TUCK BLUE
Received Aug 12, 2018 · Event occurred Apr 10, 2018
Report 3004763499-2018-00002 · MDR key 7775812
Device
Generic name
Barrier Surgical Hood
Manufacturer
Molnlycke HealthcareModel number
620105Lot number
17226504
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACTUAL MODEL # 620100-11. THIS REPORT WAS SUBMITTED FOR SIMILAR MODEL. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN IMPLEMENTED. ZERO (0) SIMILAR REPORTS HAVE BEEN RECEIVED. MONITORING FOR SAME/SIMILAR REPORTS WILL BE CONDUCTED.
Description of Event or Problem
DURING SURGERY, THE STAFF REALIZED THAT THE SURGICAL HOOD WAS FRAYING AND MATERIAL RESIDUE FELL INTO THE SURGICAL SITE. THE HOOD WAS CHANGED AND THE WOUND SITE WAS CLEANSED TO REMOVE FOREIGN MATERIAL AND EXPLORED TO CONFIRM REMOVAL. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2018 REPORTED THE PATIENT DID NOT EXPERIENCE ANY POST-OP COMPLICATIONS OR OTHER PROBLEMS ASSOCIATED WITH THE REPORTED ISSUE AND THAT THE RESIDUE HAD BEEN SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE OR EXPECTED.