MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 SL FOLEY SWIVEL SILICONE TRICOT, LATEX & SILICONE, 5 PACK - SOLD IN THE UK; STATLOCK

Catalog Number FOL0102DT

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had damage to her skin after the removal of the statlock.The patient stated that she uses the removal wipes.The patient then advised that she switched legs and something similar happened; however, it was not as bad since it was only on for 5 days.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The labeling specified on ifu pk2402029 rev.3 contains adequate instructions and contraindications for use of the statlock devices.(b)(4).The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the patient's skin was allegedly damaged after the removal of the statlock.The patient stated that she uses the removal wipes.The patient then advised that she moved the device to the opposite leg, and after 5 days of use, had a similar experience; however, reported that it was not as severe.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT, LATEX & SILICONE, 5 PACK - SOLD IN THE UK
• Type of Device: STATLOCK
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6385823
• MDR Text Key: 69328144
• Report Number: 1018233-2017-00914
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0102DT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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