ICEROSS SEAL-IN X
Received Dec 5, 2018 · Event occurred Jun 30, 2017
Report 3003764610-2018-00007 · MDR key 8132735
Product problems
- Fitting Problem
Patient
Not reported
- Pain
- Skin Irritation
- Impaired Healing
- Pain
- Skin Irritation
- Impaired Healing
Narrative
Additional Manufacturer Narrative
NO INDICATION OF MATERIAL OR MANUFACTURING FAILURE COULD BE IDENTIFIED BASED ON INFORMATION PROVIDED. THIS TYPE OF ISSUE HAS NOT BEEN RECORDED BEFORE AS A RESULT OF THIS OR PREDICATE DEVICES. NO PRODUCT WAS RETURNED AND ANALYSIS WAS PERFORMED BASED ON INFORMATION PROVIDED VIA MEDWATCH. IT IS CONCLUDED THAT THE SUBJECT IS LIKELY TO HAVE AN UNDERLYING CONDITION LEADING TO THE SEVERITY OF ULCERATION. DIABETIC PATIENTS AND PERIPHERAL VASCULAR DISEASE PATIENTS ARE KNOWN TO BE ULCER PRONE WHICH MAY ALSO HAVE CONTRIBUTED TO SAID ISSUE. AS INFORMATION IS SCARCE IN THE CLAIM AND RELATION CANNOT BE MADE TO PRODUCT MALFUNCTION, FURTHER ACTION IS NOT CONSIDERED WARRANTED.
Description of Event or Problem
PATIENT WAS FITTED WITH A 1 1/2 IN SILICONE BAND THAT FELT LIKE A "TOURNIQUET", CAUSED PAIN AND DEVELOPED A NON-HEALING BLOOD BLISTER.
Remedial action
- Patient Monitoring