MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NEGATIVE PRESSSUE WOUND THERAPY SYSTEM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

Patient Problems Burn(s) (1757); Swelling (2091)

Event Date 02/10/2015

Event Type  Injury  

Event Description

Pico was in-situ on a bedridden patient with brain damage.It was reported the patient laid on the pico pump.The patient presented with a burn and incurred blisters on the skin.The pico pump showed a burnt pin hole area on the front of the pico pump.

Manufacturer Narrative

• Brand Name: PICO SINGLE USE NEGATIVE PRESSSUE WOUND THERAPY SYSTEM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; hu3 2bn ; UK
• Manufacturer Contact: claudia odoy ; schachenallee 29; hull, hu3 2bn; aarau 5001 ; SZ 5001
• MDR Report Key: 4600121
• MDR Text Key: 18026011
• Report Number: 8043484-2015-00001
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• 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
• Patient Outcome(s): Other