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

Model Number FOL0102

Device Problems Biocompatibility (2886); Device Handling Problem (3265)

Patient Problems Hypersensitivity/Allergic reaction (1907); Blister (4537)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported that the customer had an allergic reaction to the adhesive while using foley statlock.They were having blisters spreading and urgently needs a solution.Per follow up via phone on 18apr2023, customer had been using the statlocks since (b)(6) 2023 and replaced them 16 days ago.The blisters have started to spread down to their feet with intense bleeding, and it appears to be a significant allergic reaction.Customer pharmacy, discount drug mart, advised their to use extra strength asper creme and witch hazel, but they agitated the blisters further.Customer doctor advised their to use hydrocortisone, and they would saw how their body responds to it, and customer would not be reapplying the statlocks.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event was confirmed as use related as "the patient had been using the statlock more than a week".A potential root cause for this failure could be "user deviation from instructions for use".The product was used for treatment purposes.The failure was caused by the misuse of the product.It is unknown whether the device had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "contraindications: known tape or adhesive allergies.Daily maintenance: the statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.Conduct skin assessment prior to application and repeat daily per facility protocol." h11: section a through f - the information provided by bd represents all 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 customer had an allergic reaction to the adhesive while using foley statlock.They were having blisters spreading and urgently needs a solution.Per follow up via phone on 18apr2023, customer had been using the statlocks since (b)(6) 2023 and replaced them 16 days ago.The blisters have started to spread down to their feet with intense bleeding, and it appears to be a significant allergic reaction.Customer pharmacy, discount drug mart, advised their to use extra strength asper creme and witch hazel, but they agitated the blisters further.Customer doctor advised their to use hydrocortisone, and they would saw how their body responds to it, and customer would not be reapplying the statlocks.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16895211
• MDR Text Key: 314831412
• Report Number: 1018233-2023-03278
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUGY8646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention