MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOC SL FOLEY UNKNOWN CODE; UNKNOWN STATLOCK

Model Number FOL0100

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the statlock devices from the pharmacy didn't stick and came off overnight.As per the additional information received via phone, the statlocks did not stick to the customer's skin, even after cleansing the area thoroughly.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to ¿pad material incompatible with adhesive (poor surface treatment)".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock foley product ifus were found to be adequate based on past reviews.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the statlock devices from the pharmacy didn't stick and came off overnight.As per the additional information received via phone, the statlocks did not stick to the customer's skin, even after cleansing the area thoroughly.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d1.D2, d4.H11:section a through f the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the statlock devices from the pharmacy didn't stick and came off overnight.As per the additional information received via phone, the statlocks did not stick to the customer's skin, even after cleansing the area thoroughly.

• Brand Name: STATLOC SL FOLEY UNKNOWN CODE
• Type of Device: UNKNOWN STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10309047
• MDR Text Key: 200847675
• Report Number: 1018233-2020-04707
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/28/2020; 10/01/2020
• Supplement Dates FDA Received: 08/18/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1