MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUSHION & HAND PUMP COMBO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number DG212HP

Device Problem Overfill (2404)

Patient Problem Tissue Breakdown (2681)

Event Date 01/17/2014

Event Type  Injury  

Event Description

It was reported by the customer that a patient's skin allegedly broke down due to a deflated overylay.There was patient involvement; however, no clinically relevant delay in treatment was reported.

Manufacturer Narrative

Follow-up submitted to confirm that the lot number for the overlay was not provided and the overlay was not available for evaluation.It was also confirmed that the overlay was disposed of and a replacement provided.Overlay disposed of and not available for evaluation.

Event Description

It was reported by the customer that a patient's skin allegedly broke down due to a deflated overlay.There was patient involvement; however, no clinically relevant delay in treatment was reported.

• Brand Name: CUSHION & HAND PUMP COMBO
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3625917
• MDR Text Key: 4135378
• Report Number: 0001831750-2014-01247
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2014

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: Other
• Device Catalogue Number: DG212HP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1