GLOVE SURGICAL PROTEXIS PI MICRO 2D73PM65

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for GLOVE SURGICAL PROTEXIS PI MICRO 2D73PM65 manufactured by Cardinal Health (thailand) 222 Limited.

Event Text Entries

[139103469] The device history record of the complaint lot was reviewed. The lot was inspected and released in compliance with all requirements. The customer had the sample but the manufacturing facility did not need it to be returned due to their identification of the problem. It appears that a new alternate source of polyisoprene had less tear resistance than a previous source for the same thickness control. We have resumed sourcing product from the previous supplier.
Patient Sequence No: 1, Text Type: N, H10


[139103470] Physician complained of multiple glove tears during a laparoscopic tah bso - one glove tore in multiple pieces. Some pieces were retrieved from the abdomen and some were found on the floor of the or. The surgeon did order additional antibiotics. No additional updates available on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423537-2019-00287
MDR Report Key8420674
Date Received2019-03-14
Date of Report2019-03-14
Date of Event2019-02-19
Date Mfgr Received2019-02-21
Device Manufacturer Date2018-09-30
Date Added to Maude2019-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPATRICIA TUCKER
Manufacturer Street1500 WAUKEGAN RD
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1CARDINAL HEALTH (THAILAND) 222 LIMITED
Manufacturer Street7/111 MOO 4 HIGHWAY #331, MABY
Manufacturer CityRAYONG 21140
Manufacturer CountryTH
Manufacturer Postal Code21140
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGLOVE SURGICAL PROTEXIS PI MICRO
Generic NameSURGEON'S GLOVES
Product CodeKGO
Date Received2019-03-14
Catalog Number2D73PM65
Lot NumberTS18090309
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH (THAILAND) 222 LIMITED
Manufacturer Address7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-14

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