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

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

Patient Problems Tissue Damage (2104); Injury (2348); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 obese patients being treated in the facility were experiencing a high number of deep tissue injuries with use.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿materials of construction selected are not biocompatible¿.A potential root cause for this failure could be ¿inadequate biological evaluation".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required due to product code z097fo is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the statlock labeling is found to be adequate based on past reviews.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 the obese patients being treated in the facility were experiencing a high number of deep tissue injuries with use.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8992445
• MDR Text Key: 157429465
• Report Number: 1018233-2019-05541
• Device Sequence Number: 1
• Product Code: EYJ
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other