MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC; STAPLE, FIXATION, BONE

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown bme implant /unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient who been implanted on unknown date with a bme implant.Subsequently, the patient developed an allergy to nitenol (nickel-titanium alloy).The implant was removed on an unknown date.Patient information and status is unknown.This report is for an unknown bme implant.This is report 1 of 1 for (b)(4).

• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lange east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6607526
• MDR Text Key: 76504851
• Report Number: 1649263-2017-10010
• Device Sequence Number: 1
• Product Code: JDR
• 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
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention