MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 3539700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the patient had a loss of substance on the right lower limb following an acute bacterial necrotizing dermopanniculitis.Dermal substitute integra (idrt) was applied on all loss of substance on (b)(6) 2019 and removal of the silicone layer followed by a skin autograft on (b)(6) 2019.Skin sampling was done with an electrical dermatome (0.011 inches thick planned) at the level of the right and left thigh.Deep lesions of the left thigh, at the level of the flank muscle, when using the dermatome.

Event Description

N/a.

Manufacturer Narrative

Dhr no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.Under evaluation it was found that the dermatome was received in good condition.The cuts did not create waves or did to deep cutting.Evaluation was unable to conclusively verify customer information as valid.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8809840
• MDR Text Key: 151705537
• Report Number: 3004608878-2019-00189
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR