MAUDE Adverse Event Report: SGP01 SINGAPORE SHOECOVER DURAFIT BLUE; COVER, SHOE, OPERATING-ROOM

Model Number	4850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, the device history record (dhr) could not be traced.No sample was returned at the time of the investigation.If the sample becomes available, it can be forwarded to us so further evaluation can be performed.According to the supplier, this product code 4850 is a shoecover that does not have an anti-skid coating.Therefore, this product does not contain an anti-skid function.With a review of this product history record, the visual inspect results of all the products produced have met the customer requirements.The manufacturing/transferring/inventory process and the environment of the product have not changed.The materials used in the products have not changed.All the products of this code have passed inspection before launch.It was recommended to the customer, to choose an alternative shoecover that provides an anti-skid function to better serve the situation.From the investigation, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that shoe cover durafit blue 4850 becomes very slippery if the floor gets wet ¿for whatever reason¿ and a surgical tech fell on a wet floor in front of the scrub sink while wearing the shoecovers.The surgical tech suffered a new tear lateral meniscus, left knee; marked worsening of anterior cruciate ligament tear; worsened partial thickness tear posterior cruciate ligament; possible tear of medial cruciate ligament; worsened joint effusion and edema along the medial femoral condyle and tibial plateau.Surgery will be provided however the employee is continuing to work performing, the usual duties.
Additional Manufacturer Narrative
Mdr supplemental report being filed due to all entries in the f-fields on the inital report were entered incorrectly, showing cardinal health as the importer, which is in error.All f-fields should remain unmarked.No other changes to the report are required.

• Brand Name: SHOECOVER DURAFIT BLUE
• Common Device Name: COVER, SHOE, OPERATING-ROOM
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• MDR Report Key: 9513072
• Report Number: 1423537-2019-00386
• Device Sequence Number: 2638090
• Product Code: FXP
• UDI-Device Identifier: 10630140019128
• UDI-Public: 10630140019128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4850
• Device Catalogue Number: 4850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/26/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 120