MAUDE Adverse Event Report: WRIGHT & FILIPPIS INC STUMP SHRINKER; COVER, LIMB

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

Patient was status post knee amputation.A shrinker was applied by wright-fillippis rep and it was later determined that the shrinker might have been applied improperly or might have been too tight.The patient did experience harm to skin - deep tissue injury to right thigh, requiring additional monitoring by wound care and interventions for the patient's skin.

• Brand Name: STUMP SHRINKER
• Type of Device: COVER, LIMB
• Manufacturer (Section D): WRIGHT & FILIPPIS INC; 2845 crooks road; rochester hills MI 48309
• MDR Report Key: 5920457
• MDR Text Key: 53725206
• Report Number: 5920457
• Device Sequence Number: 1
• Product Code: IPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; OTHER, PATIENT CONDITION MIGHT HAVE BEEN A FACTO
• Patient Outcome(s): Other
• Patient Age: 48 YR