MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK

Catalog Number FOL0102

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pressure Sores (2326)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that upon removal of the statlock, a large sore was present underneath.The statlock was in use for approximately 1.5 weeks.The nurse stated that the statlock was placed on the lower part of the leg and the sore could have possible been cause by contamination under the device.Clinical evaluation of photo: the photo showed a wound on the inner right thigh.The wound appeared to be approximately the size of a quarter, with dark red wound bed.The edges were well defined, and circular in shape.The wound bed appeared dry and scabbed.No drainage could be seen in the photo.Outside of the wound edges was a light pink redden area.The wound had a crater like appearance and would be classified as a stage iii pressure sore.(b)(6).(b)(6) 2019.Per additional information from the ibc via email on 29apr2019; the patient was swab tested for an infection on the sore and the results were negative for an infection.The sore was treated daily with a betadine solution for a few days and has since healed leaving a small amount of scarring.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that upon removal of the statlock, a large sore was present underneath.The statlock was in use for approximately 1.5 weeks.The nurse stated that the statlock was placed on the lower part of the leg and the sore could have possible been cause by contamination under the device.Clinical evaluation of photo: the photo showed a wound on the inner right thigh.The wound appeared to be approximately the size of a quarter, with dark red wound bed.The edges were well defined, and circular in shape.The wound bed appeared dry and scabbed.No drainage could be seen in the photo.Outside of the wound edges was a light pink redden area.The wound had a crater like appearance and would be classified as a stage iii pressure sore.Tschlager (b)(6) 2019 per additional information from the ibc via email on (b)(6) 2019; the patient was swab tested for an infection on the sore and the results were negative for an infection.The sore was treated daily with a betadine solution for a few days and has since healed leaving a small amount of scarring.

Manufacturer Narrative

The reported event was confirmed as user related.The visual evaluation noted one photo sample was received.Visual evaluation of the photo sample noted, there was a large red mark left on the skin where the swivel base was assumed to be sitting.There was adhesive residue from the pad remaining on the skin of the patient, indicating where the statlock was placed.It was noted in the event that the device was in place for 1.5 weeks.The ifu states that it should be changed "at least every seven days", therefore the device was used longer than it was supposed to be.The root cause for this failure was user-related due to the patient wearing the device longer than 7 days.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "4.Daily maintenance: a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.".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.

Event Description

It was reported that upon removal of the statlock, a large sore was present underneath.The statlock was in use for approximately 1.5 weeks.The nurse stated that the statlock was placed on the lower part of the leg and the sore could have possible been cause by contamination under the device.Clinical evaluation of photo: the photo showed a wound on the inner right thigh.The wound appeared to be approximately the size of a quarter, with dark red wound bed.The edges were well defined, and circular in shape.The wound bed appeared dry and scabbed.No drainage could be seen in the photo.Outside of the wound edges was a light pink redden area.The wound had a crater like appearance and would be classified as a stage iii pressure sore.(b)(6) 2019.Per additional information from the ibc via email on 29apr2019; the patient was swab tested for an infection on the sore and the results were negative for an infection.The sore was treated daily with a betadine solution for a few days and has since healed leaving a small amount of scarring.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8575490
• MDR Text Key: 143942473
• Report Number: 1018233-2019-02291
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/29/2019; 06/13/2019
• Supplement Dates FDA Received: 05/13/2019; 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other